McNeil's May Day: Children's Tylenol, Motrin, Zyrtec & Benadryl Products Recalled

Quality issues at manufacturing plant triggers May 1st recall of all unexpired production batches

McNeil Consumer Healthcare has recalled all unexpired lots of the following over-the-counter (OTC) medications:

• CONCENTRATED TYLENOL® INFANTS’ DROPS – various sizes and flavors
• CHILDREN’S TYLENOL® SUSPENSION – various sizes and flavors
• CHILDREN’S TYLENOL® DYE-FREE SUSPENSION, 4 oz. – Cherry flavor
• CHILDREN’S TYLENOL® PLUS SUSPENSION, 4 oz. – various varieties (including dye-free) and flavors
• CONCENTRATED MOTRIN® INFANTS’ DROPS – various sizes; Berry and dye-free Berry flavors
• CHILDREN’S MOTRIN® SUSPENSION – various sizes and flavors
• CHILDREN’S ZYRTEC® liquids – various sizes, varieties (including dye-free and sugar- and dye-free) flavors
• CHILDREN'S BENADRYL® ALLERGY, 4 oz. – Bubble gum flavored liquid

Two of the recalled items – Concentrated Tylenol® Infants' Drops (0.5 oz. Grape Flavor) and Concentrated Motrin® Infants' Drops (0.5 oz. Berry Flavor) – also are included in JOHNSON'S® Baby Relief Kit. McNeil Consumer Healthcare is a Johnson & Johnson company.

The recalled OTC products were sold in the United States, Canada, the Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

FDA has supplemented the McNeil recall notice with a separate news release containing guidance for consumers, and providing the following explanation for this recall:

"McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use."

Today's recall represents the latest in a series of safety and quality recalls that have bedeviled McNeil's manufacturing operations since an FDA inspection of the company's Puerto Rico production facility – conducted between October 22, 2009 and January 8, 2010 – uncovered significant problems at that location.

According to a report on MarketWatch, the products covered by today's recall were manufactured in a Pennsylvania production facility, and not in the Puerto Rico plant. Additional details on this, and earlier, McNeil product recalls can be accessed on a special McNeil website at www.mcneilproductrecall.com.

Consumers or health professionals wishing to report an adverse reaction to one of the recalled products can do so using FDA's MedWatch program.

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McNeil's Migraine

FDA releases inspection report for McNeil's Fort Washington, PA production plant; McNeil apologizes to consumers

It's not often that FDA issues a separate consumer warning in conjunction with a manufacturer's voluntary recall. So when I saw FDA's May 1, 2010 news release, I had a hunch that something was up.

In January of this year, McNeil recalled a broad range of OTC pharmaceuticals produced at its Puerto Rico manufacturing facility after an FDA inspection found numerous deficiencies in the plant's operations. As a result of the Puerto Rico problems, the company undertook a "... comprehensive quality assessment across its manufacturing operations..."

Unfortunately for McNeil and its customers, that comprehensive quality assessment had not yet paid dividends in the Fort Washington, PA manufacturing plant by the time FDA arrived to inspect the facility on April 19, 2010. FDA's inspection lasted from April 19th to April 30th, and uncovered a long list of operational deficiencies.

Here are just a few of the problems highlighted in the FDA report:

• Raw material ... had known contamination with gram negative organisms and were approved for use to manufacture several finished lots of Children's and Infant's Tylenol drug products, which remain within expiration dates on the market.
• Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
• A thorough investigation or any additional analytical testing was not conducted for Infants Dye-Free Tylenol Suspension Drops, Cherry, 80 mg/0.8mL, Formula ... for ... lots that were super potent and confirmed to fail release specification of ... Acetominaphen (APAP) assay.
• There is no written testing program designed to assess the stability characteristics of drug products.
• Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.

In response to FDA's release of the 17-page inspection report, McNeil released the following statement:

We have no higher concern than providing parents with the highest quality products for their children. The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate. While the chance of serious adverse medical reaction is remote, we apologize to those who rely on our medicines for the concern and inconvenience this recall may have caused. We will provide a detailed response to the FDA on their observations, and work diligently to ensure that they are addressed.

We have temporarily suspended production at our Fort Washington, PA plant, where the observations were made. We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there.

This step comes on top of others we already have taken to ensure quality compliance. Early this year we initiated a comprehensive assessment of quality and manufacturing systems across our operations. We have committed extensive internal resources to this effort, and brought in independent outside experts to assist us.

We will continue to work in close consultation with the FDA to take corrective action and ensure that our quality operations meet the high standards that consumers expect from us.

We remind consumers with questions about the recall of certain infants' and children's products to contact us at: www.mcneilproductrecall.com; or call us at 1-888-222-6036.

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Recall Roundup: November 17, 2010

Here is today's list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please click here or submit your request using the sidebar link. Please include "subscribe eFoodAlert" in the subject line.

United States

• OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets in cherry and grape flavors and all product lots of Junior Strength MOTRIN® Caplets, 24 count. The recall was initiated after a review conducted as part of McNeil's Comprehensive Action Plan revealed insufficiencies in the development of the manufacturing process. The recalled products were distributed to retailers nationwide.
• OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls ROLAIDS® Extra Strength Softchews, Cherry Flavor (36-count package; Lot #0053AG2), following consumer complaints of an uncharacteristic consistency or texture, traced to crystallized sugar in the product. The recalled product was distributed to retailers nationwide.

Canada

• Food Safety Recall: Atlantic Prepared Food Limited (APFL, Establishment number 514; Alberton, PEI) recalls Ham and Cheese Sandwich was packaged in a 185 g package bearing Best Before 10 DE 06; UPC 0 55742 98002 8 and a legend with an establishment number 514. The product is known to have been distributed in Prince Edward Island and Nova Scotia, and may have been distributed in other Atlantic provinces.
• OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets in cherry and grape flavors. The recall was initiated after a review conducted as part of McNeil's Comprehensive Action Plan revealed insufficiencies in the development of the manufacturing process.

Europe

• Food Safety Recall (UK): Warburtons Ltd. recalls Warburtons 6-Pack Crumpets (best before 22/11/10 and 23/11/10) due to possible contamination with small pieces of aluminium. The recalled crumpets were distributed within Yorkshire, Lancashire, Merseyside, West Midlands, North Wales and Greater Manchester in Sainsbury's stores and may also have been distributed to other retailers in those areas.
• Pharmaceutical Product Safety Recall (UK): EBEWE Pharma Ges.m.b.H.Nfg.KG recalls certain batch numbers of Fluorouracil 50 mg/ml Solution for Injection 10 ml and Methotrexate 100 mg/ml Solution for Injection 10, because glass particles have been identified in a small number of vials during routine testing.
• Pharmaceutical Product Safety Recall (France): Janssen-Cilag recalls certain lots of Velcade 3.5mg powder for injectable solution, due to the presence of visible particles in suspension in certain vials of the affected lots.
• Food Safety Notification (EU #2010.1564): Parasitic infestation with nematodes (8 dead larvae) of frozen pike (Esox lucius) fillets from the Russian Federation, via Lithuania; distributed to Poland.
• Food Safety Notification (EU #2010.1565): Too high content of E 210 - benzoic acid in mulled wine from Sweden; distributed to Finland, Norway and Sweden.
• Food Safety Notification (EU #2010.1566): Listeria monocytogenes in smoked salmon from Spain; distributed to Italy.
• Food Safety Notification (EU #2010.1567): Unauthorised use of colour E 143 - fast green FCF / FD&C green in canned soft drink from Thailand, via the Netherlands; distributed to Finland.
• Food Safety Notification (EU #2010.1568): Mold infestation in walnut kernels from Ukraine; distributed to Denmark.
• Food Safety Notification (EU #2010.1569): Metal wire fragments (2 cm) in lollipop from Turkey; distributed to the United Kingdom.

Latin America and the Caribbean

• OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets in cherry and grape flavors. The recall was initiated after a review conducted as part of McNeil's Comprehensive Action Plan revealed insufficiencies in the development of the manufacturing process. The recalled products were distributed in Belize, Barbados, Puerto Rico, St. Martin and St. Thomas.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket's recall web site.

• A&P
• Big Y® World Class Market®
  
• BJ's Wholesale Club, Inc.
  
• Bloom
  
• Brookshire's
  
• Costco Wholesale Corporation (US stores)
  
• Costco Wholesale Canada Ltd.
  
• EDEKA (Germany)
• Food City
  
• Food Lion
  
• Giant Food LLC
• Gros Cidac (Italy)
• Hannaford Brothers Co.
  
• Harris Teeter
• H-E-B
• The Kroger Company*
  
• Price Chopper
  
• Raley's
• Roundy's Supermarkets, Inc.
  
• Sainsbury's
  
• ShopRite
  
• Stop & Shop
• Sweetbay Supermarkets
• Target
  
• Top Food & Drug
• Tops Friendly Markets
  
• Wal-Mart Stores, Inc.
  
• Wegmans
  
• Whole Foods Market
  
• WinCo Foods
• Winn-Dixie Stores, Inc.
  

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.

Recall Roundup: July 9, 2010

Here is today's list of food safety recalls, product withdrawals and allergy alerts. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please click here or submit your request using the sidebar link. Please include "subscribe eFoodAlert" in the subject line.

United States

• OTC Pharmaceutical Safety Recall: McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., recalls 21 lots of over-the-counter medicines that were manufactured in the company's Puerto Rico facility and that may contain trace amounts of a chemical called 2,4,6-tribromoanisole. The recall includes specific dosage formats and lot codes of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin IB, Tylenol Extra Strength, and Tylenol PM products. The recalled products were sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. Please follow the link to the McNeil recall notice for additional details on the recalled products.
• Food Safety Recall (Update): USDA updates the retail distribution list for bison meat products that were recalled recently by Rocky Mountain Natural Meats due to contamination with E. coli O157:H7.
• Food Safety Recall: Miravalle Foods, Inc. (S. El Monte, CA) recalls 37,318 lbs. of Miravalle Chile California and Miravalle Chile Nuevo Mexico Peppers distributed between March 15th and May 6th 2010 to some customers in California, Colorado, Utah, North Carolina, Nebraska, Idaho, Oregon and Nevada because they may be contaminated with Salmonella. The recalled was initiated after FDA detected Salmonella in a random sample of the peppers.
• Food Safety Recall: J. Hellman Frozen Foods, Inc. (Los Angeles, CA) recalls 992 cases (4,960 retail units) of Señor Mexicano™ Avocado Pulp (A 21 04 10 / A 21 04 12), after FDA finds Listeria monocytogenes in a random sample of the product. The recalled avocado pulp was distributed in California and Hawaii.
• Dietary Supplement Safety Alert: FDA warns that Que She, marketed as an herbal weight loss supplement, contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions. An FDA lab analysis of the product found that it contains fenfluramine, propranolol, sibutramine, and ephedrine. Que She has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas.

Europe

• Allergy Alert Notification (EU #2010.0916): Undeclared peanut (9 mg/kg - ppm) in coconut ice-cream bar from Poland; distributed in the Czech Republic.
• Food Safety Recall (France): Covial (Establishment #FR 15 014 032 CE) recalls 3.8 tonnes (3,800 kg or 8,378 lb) of fresh ground meat and vacuum-packed ground meat after detecting E. coli O157:H7 in a sample. The recalled meat was sold under the Carrefour (Use by dates of July 6 and July 7) and Casino (Use by date of July 7) brand names. The recalled meat was sold in Carrefour, Carrefour Market, Carrefour City, Carrefour Contact, Shopi, 8 À Huit, Marché Plus, Géant Casino and Casino supermarkets. Carrefour products were available in Aquitaine, Auvergne, Bourgogne, Centre, Franche-Comté, Haut-Rhin, Languedoc-Roussillon, Limousin, Midi-Pyrénées, Poitou-Charentes and Rhône-Alpes; the Casino-labelled meat was sold in the central and south-west regions of France (recall notice forwarded by Albert Amgar).
• Food Safety Recall (Denmark): Nordic Seafood A/S recalls fresh tuna steaks, due to illegal treatment with carbon monoxide.
• Food Safety Recall (Denmark): Altia Denmark recalls Santa Veda CS boxed wine, sold in SuperGros stores, because some of the boxes are bulging.
• Food Safety Notification (EU #2010.0912): Residue level above MRL for oxytetracycline in chilled horse meat from Argentina, via Belgium; distributed in Germany and Switzerland.
• Food Safety Notification (EU #2010.0913): Potentially pathogenic bacteria in sardines in olive oil from Morocco; distributed in Italy and Hong Kong.
• Food Safety Notification (EU #2010.0914): Listeria monocytogenes in smoked salmon from Poland; distributed in France and Poland.
• Food Safety Notification (EU #2010.0915): Monocrotophos (pesticide) in fresh okra from India; distributed in Germany.
• Food Safety Notification (EU #2010.0917): Parasitic infestation with Anisakis of frozen hake from Spain, via Latvia; distributed in Lithuania.
• Food Safety Notification (EU #2010.0918): Listeria monocytogenes in Lavistown cheese from Ireland; distributed in Ireland and the United Kingdom.
• Food Safety Notification (EU #2010.0919): Mercury in frozen sliced swordfish from Portugal; distributed in Italy.
• Food Safety Notification (EU #2010.0920): Salmonella spp. in sliced dry turkey sausage from France; distributed in France and the United Arab Emirates.
• Food Safety Notification (EU #2010.0921): Glass fragment (2x4 mm) in potato salad from Germany; distributed in Denmark.
• Animal Feed Safety Notification (EU #2010.0922): Salmonella in rapeseed meal from Switzerland; distributed in Sweden.
• Animal Feed Safety Notification (EU #2010.0923): Salmonella cubana in soya pellets from Brazil, via Aruba and via Germany; distributed in Sweden.
• Animal Feed Safety Notification (EU #2010.0924): Excessive Enterobacteriaceae in poultry meal from Germany; distributed in Belgium.
• Food Safety Notification (EU #2010.0925): Aflatoxins in red pepper powder from China; distributed in Ireland and the United Kingdom.
• Food Safety Notification (EU #2010.0927): Mercury in frozen sliced swordfish from Portugal; distributed in Italy.
• Animal Feed Safety Notification (EU #2010.0928): Feather meal (possible contamination) in poultry meal from Spain; distributed in Spain.
• Consumer Product Safety Notification (EU #2010.0929): Migration of formaldehyde from melamine bowls from China, via Spain; distributed in Slovenia.
• Consumer Product Safety Notification (EU #2010.0930): Migration of formaldehyde from melamine bowls from China, via Italy; distributed in Slovenia.
• Food Safety Notification (EU #2010.0931): Salmonella typhimurium DT 104 - multiresistant in pork tenderloin without chain muscle from Germany; distributed in Denmark.
• Food Safety Notification (EU #2010.0932): Salmonella in raw sausage from Poland; distributed in the Czech Republic, Poland and Slovakia.
• Food Safety Notification (EU #2010.0933): Metal fragment in ice cream from Italy; distributed in Italy and Malta.
• Food Safety Notification (EU #2010.0934): Aflatoxins in ground nutmeg from India, via Poland; distributed in Czech Republic.
• Animal Feed Safety Notification (EU #2010.0935): Salmonella cubana in soya pellets from Brazil, via Aruba and via Germany; distributed in Sweden.
• Consumer Product Safety Notification (EU #2010.0936): Migration of formaldehyde from plastic bowl from China; distributed in Slovenia.
• Food Safety Notification (EU #2010.0937): Risk of breakage (due to glass deformation) of glass jars containing fruit puree from Slovenia; distributed in Bosnia and Herzegovina, Croatia, Kosovo, Lithuania, Macedonia, Montenegro and Slovenia.

Asia, Africa and the Pacific Islands

• OTC Pharmaceutical Safety Recall: McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., recalls 21 lots of over-the-counter medicines that were manufactured in the company's Puerto Rico facility and that may contain trace amounts of a chemical called 2,4,6-tribromoanisole. The recall includes specific dosage formats and lot codes of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin IB, Tylenol Extra Strength, and Tylenol PM products. The recalled products were sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. Please follow the link to the McNeil recall notice for additional details on the recalled products.
• Food Safety Seizure (China): Chinese food safety officials in Qinghai province have seized 64 tonnes of raw dairy materials contaminated with melamine. Test samples showed the milk powder carried up to 500 times the maximum allowed level of the chemical.
• Food Safety Notification (EU #2010.0913): Potentially pathogenic bacteria in sardines in olive oil from Morocco; distributed in Hong Kong.
• Food Safety Notification (EU #2010.0920): Salmonella spp. in sliced dry turkey sausage from France; distributed in the United Arab Emirates.

Australia and New Zealand

• Food Safety Recall (Australia): On the order of Victoria health authorities, Kyvalley Farms 500ml bottles of chocolate-flavoured reduced-fat milk with a use-by date of July 11 have been withdrawn from sale, because the milk may be contaminated with a chemical sanitizer.

Latin America and the Caribbean

• OTC Pharmaceutical Safety Recall: McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., recalls 21 lots of over-the-counter medicines that were manufactured in the company's Puerto Rico facility and that may contain trace amounts of a chemical called 2,4,6-tribromoanisole. The recall includes specific dosage formats and lot codes of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin IB, Tylenol Extra Strength, and Tylenol PM products. The recalled products were sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. Please follow the link to the McNeil recall notice for additional details on the recalled products.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket's recall web site.

• A&P
• Big Y® World Class Market®
  
• BJ's Wholesale Club, Inc.
  
• Bloom
  
• Brookshire's
  
• Costco Wholesale Corporation (US stores)
  
• Costco Wholesale Canada Ltd.
  
• EDEKA (Germany)
• Food City
  
• Food Lion
  
• Giant Food LLC
• Gros Cidac (Italy)
• Hannaford Brothers Co.
  
• Harris Teeter
  
• Harvey's Supermarket
  
• H-E-B
• The Kroger Company*
  
• Price Chopper
  
• Raley's
• Roundy's Supermarkets, Inc.
  
• Sainsbury's
  
• ShopRite
  
• Stop & Shop
• Sweetbay Supermarkets
• Target
  
• Top Food & Drug
• Tops Friendly Markets
  
• Wal-Mart Stores, Inc.
  
• Wegmans
  
• Whole Foods Market
  
• WinCo Foods
• Winn-Dixie Stores, Inc.
  

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.

Recall Roundup: November 29, 2010

Here is today's list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please click here or submit your request using the sidebar link. Please include "subscribe eFoodAlert" in the subject line.

United States

• OTC Pharmaceutical Recall (Reprise): McNeil Consumer Healthcare has recalled Rolaids® Extra Strength Softchews, Cherry Flavor, 36-count pkg (Lot #0053AG2), distributed in the USA, after consumer complaints of an uncharacteristic consistency or texture were traced to crystallized sugar in the product. The recalled item was manufactured by a third part for McNeil.
• OTC Pharmaceutical Recall (Reprise): McNeil Consumer Healthcare has recalled all product lots of Junior Strength MOTRIN® Caplets, 24-count (distributed in the USA only), and all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets, cherry and grape flavors (distributed in the USA and exported to other countries and territories as shown below), after a review revealed insufficiencies in the development of the manufacturing process.
• OTC Pharmaceutical Recall (Reprise): McNeil Consumer Healthcare has recalled three TYLENOL® Cold Multi-Symptom liquid products in order to update labeling for these products. The recalled products were distributed in the USA.

Canada

• Food Safety Recall: Sobeys Inc. (Stellarton, NS) recalls all in-store packaged assorted cold cut subs containing cooked ham, salami and processed cheese sold in Foodland stores in the Atlantic Provinces (best before dates up to and including November 29, 2010), because they products may be contaminated with Listeria monocytogenes. The recalled sandwiches are associated with a recall announced late last week by APFL (PEI) of sandwiches made using processed cheese slices that were supplied by Saputo Inc., and were suspected of being contaminated with Listeria monocytogenes.
• OTC Pharmaceutical Recall (Reprise): McNeil Consumer Healthcare has recalled all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets, cherry and grape flavors, manufactured in the USA and exported to Canada, after a review revealed insufficiencies in the development of the manufacturing process.
• Consumer Product Safety Recall: Loblaw Companies Limited recalls Everyday Essentials™ 500mL and Joe Fresh Style™ 350mL Double Wall Stainless Steel Food Jars, because the jars may present a safety hazard. There is a potential for the lid to pop off from the jar when it contains a hot liquid. The recalled thermos-type jars are sold nationally at Loblaw corporate, franchise and affiliated independent stores.

Europe

• Pharmaceutical Product Safety Recall (UK): Merck Sharp & Dohme Limited recalls ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen (several expiry dates), because a defect in the glass stopper of the cartridge has been identified in a very small number of prefilled pens, and sterility assurance cannot be guaranteed in the affected packs.
• Food Safety Notification (EU #2010.1611): Aflatoxins in roasted and salted pistachio nuts from Turkey; distributed to Germany.
• Food Safety Notification (EU #2010.1613): Unauthorised substance isofenphos-methyl in chopped pumpkin seeds from Austria; distributed to Germany.
• Food Safety Notification (EU #2010.1614): Aflatoxins in dried granulated sweet chestnuts from Italy; distributed to Switzerland.
• Food Safety Notification (EU #2010.1615): Aflatoxins in dried sweet chestnut flakes from Italy; distributed to Switzerland.
• Food Safety Notification (EU #2010.1616): Aflatoxins in sweet chestnut flour from Italy; distributed to Switzerland.
• Food Safety Notification (EU #2010.1617): Salmonella enteritidis in poultry meat preparation from Poland; distributed to Slovakia.
• Food Safety Notification (EU #2010.1618): Aflatoxins in salted roasted pistachio nuts from Iran, via the Slovak Republic; distributed to the Czech Republic.
• Food Safety Notification (EU #2010.1619): Dioxins and dioxin-like polychlorobifenyls in shrimp shell meal from Morocco; distributed to France.
• Food Safety Notification (EU #2010.1621): Unlabelled irradiation of hot & sour sauce for noodles from China; distributed to the United Kingdom.
• Consumer Product Safety Notification (EU #2010.1622): Migration of chromium from steak knife sets from Italy; distributed to Italy and Switzerland.
• Food Safety Notification (EU #2010.1623): Salmonella and Salmonella Tennessee in frozen vegetable steak from Slovenia; distributed to Slovenia.
• Food Safety Notification (EU #2010.1624): Hepatitis A virus in dates from Algeria, via Belgium; distributed to the Netherlands.
• Food Safety Notification (EU #2010.1625): Unauthorised substance malachite green in trouts (Salmo Trutta) from Germany; distributed to Austria, Germany, Italy and Luxembourg.
• Food Safety Notification (EU #2010.1626): Listeria monocytogenes in gorgonzola cheese from Italy; distributed to Italy and the United Kingdom.

Australia and New Zealand

• Allergy Alert (Australia): Haigh's Manufacturing Pty Ltd. recalls Haigh's Chocolates Gourmet Christmas Cake (450g cake in clear plastic box; Best before dates 19-Sept-11 and 02-Oct-11), due to the presence of undeclared food additives. The recalled item is sold only through Haigh's stores, and was distributed only in South Australia, Victoria and New South Wales.

Latin America and the Caribbean

• OTC Pharmaceutical Recall (Reprise): McNeil Consumer Healthcare has recalled all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets, cherry and grape flavors, manufactured in the USA and exported to Belize, Barbados, Puerto Rico, St. Martin and St. Thomas, after a review revealed insufficiencies in the development of the manufacturing process.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket's recall web site.

• A&P
• Big Y® World Class Market®
  
• BJ's Wholesale Club, Inc.
  
• Bloom
  
• Brookshire's
  
• Costco Wholesale Corporation (US stores)
  
• Costco Wholesale Canada Ltd.
  
• EDEKA (Germany)
• Food City
  
• Food Lion
  
• Giant Food LLC
• Gros Cidac (Italy)
• Hannaford Brothers Co.
  
• Harris Teeter
• H-E-B
• The Kroger Company*
  
• Lucky Supermarkets
• Price Chopper
  
• Publix
• Raley's
• Roundy's Supermarkets, Inc.
  
• Sainsbury's
  
• ShopRite
  
• Stop & Shop
• Sweetbay Supermarkets
• Target
  
• Top Food & Drug
• Tops Friendly Markets
  
• Wal-Mart Stores, Inc.
  
• Wegmans
  
• Whole Foods Market
  
• WinCo Foods
• Winn-Dixie Stores, Inc.
  

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.

FDA Issues Warning Letter Over Tylenol Defects

Cites lack of McNeil and J&J response to FDA's concerns

FDA has issued a formal Warning Letter to McNeil Consumer Healthcare over the Company's poor response to quality and safety issues relating to yesterday's international recall of Tylenol, Motrin, Rolaids and other brands of OTC pharmaceutical products.

The massive recall was triggered by numerous complaints of musty, moldy odors, as well as gastrointestinal upsets. Affected brands include:

• Children's Motrin - Caplets and Chewables
• Children's Tylenol - Meltaways
• Benadryl - Tablets
• Extra Strength Tylenol - Caplets, Cool Caplets, EZ Tablets and Rapid Release Gelcaps
• Motrin IB - Caplets and Tablets
• Regular Strength Tylenol - Caplets and Tablets
• Rolaids - Chewables
• Simply Sleep - Caplets
• St. Joseph Aspirin - Chewables and Tablets
• Tylenol 8 Hour - Caplets
• Tylenol Arthritis - Caplets and Geltabs
• Tylenol PM - Caplets, Geltabs and Rapid Release Gelcaps

In its Warning Letter, FDA cited a lack of responsiveness on the part of McNeil Consumer Healthcare and its parent company, Johnson & Johnson, stating:

"We are aware of the complaint information available to your company, the sequence of events, and the extent of your firm's follow up measures during this period. We have concluded that your company did not conduct a timely, comprehensive investigation.

Your initial investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely. Numerous complaints were received over a four month period in 2008 before they were considered a trend and before actions were initiated to determine the root cause. When microbiological testing in August 2008 did not support an initial speculation that microbial contamination was the root cause of the odor, the investigation was closed. No other possible root causes were pursued. Your firm lacked adequate justification for this decision."

FDA also noted,

"The Agency is concerned about the response of Johnson & Johnson (J&J) to this matter. It appears that when J&J became aware of FDA's concerns about the thoroughness and timeliness of McNeil's investigation, whether all potentially affected products had been identified, and whether the recall was adequate in scope, J&J did not take appropriate actions to resolve these issues. Corporate management has the responsibility to ensure the quality, safety, and integrity of its products. Neither upper management at J&J nor at McNeil Consumer Healthcare assured timely investigation and resolution of the issues."

The recalled products were distributed throughout the Americas, as well as to the United Arab Emirates and Fiji.

Please check your medicine cabinet for the products listed above, and follow this live link to the recall notice for a complete list of recalled products and lot numbers.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please click here or submit your request using the sidebar link.

Tylenol Quality Issues Give McNeil A Headache

FDA finds several serious deficiencies at Puerto Rico facility. Recall expands.

McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, has expanded an earlier US recall of TYLENOL® Arthritis Pain 100 count with EZ-OPEN CAP to include a wider range of over-the-counter products distributed in the Americas, the United Arab Emirates, and Fiji.

The broadened recall includes selected production lots of:

• Children's Motrin - Caplets and Chewables
• Children's Tylenol - Meltaways
• Benadryl - Tablets
• Extra Strength Tylenol - Caplets, Cool Caplets, EZ Tablets and Rapid Release Gelcaps
• Motrin IB - Caplets and Tablets
• Regular Strength Tylenol - Caplets and Tablets
• Rolaids - Chewables
• Simply Sleep - Caplets
• St. Joseph Aspirin - Chewables and Tablets
• Tylenol 8 Hour - Caplets
• Tylenol Arthritis - Caplets and Geltabs
• Tylenol PM - Caplets, Geltabs and Rapid Release Gelcaps

Some consumers have reported an unusual moldy, musty, or mildew-like odor that, in a small number of cases, triggered episodes of nausea, stomach pain, vomiting, or diarrhea. The company believes that the odor is due to traces of the chemical 2,4,6-tribromoanisole (TBA). The health effects of TBA have not been extensively studied, but are believed not to be serious. TBA is generated when certain molds break down a fungicide that sometimes is applied to wood used to make shipping pallets.

McNeil first became aware of the problem in 2008, when it received more than 60 complaints of a musty odor in two lots of Tylenol Arthritis Relief Caplets, including at least 8 complaints of "gastrointestinal adverse events." In September 2008, the Company confirmed the presence of the odor, but did no testing to evaluate the possibility of a chemical contaminant or product deterioration. Nor did McNeil issue a field alert.

The Company received additional complaints in the spring and summer of 2009, but did not issue a field alert until September 18th, and did not initiate a product recall until December 4th, while undergoing an FDA inspection.

The FDA inspection report, posted earlier this week on the agency's website, reveals numerous problems at the Puerto Rico factory where the recalled products are manufactured. The main findings include:

1. An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
2. Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
3. The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4. There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
5. Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
6. Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
7. Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

Please check your medicine cabinet for the products listed above, and follow this live link to the recall notice for a complete list of recalled products and lot numbers.

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Recall Roundup: May 1, 2010

Here is today's list of food safety recalls, product withdrawals and allergy alerts. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please click here or submit your request using the sidebar link. Please include "subscribe eFoodAlert" in the subject line.

United States

• Allergy Alert: Humei Trading Inc. recalls Dried Pachyrhizus, (Net Wt. 350g/12.32 oz; Product of China), because they contain undeclared sulfites. The recalled product was distributed in the New York City area.
• Allergy Alert: Northern Food I/E recalls 100 gram packages of Havista brand "white fungus" (Best Before 09/10/2011) because they contain undeclared sulfites. The recalled product was distributed in retail stores in New York and New Jersey.
• OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls all non-expired lots of Children’s and Infants’ Tylenol, Motrin, Benadryl and Zyrtec liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait, because some of the products may not meet required quality standards. Please navigate to the live link for a list of recalled products.

Canada

• OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls all non-expired lots of Children’s and Infants’ Tylenol, Motrin, Benadryl and Zyrtec liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait, because some of the products may not meet required quality standards. Please navigate to the live link for a list of recalled products.

Europe

• Allergy Alert (France): Nestlé recalls Herta Knacki Ball Original Cocktail Sausage (200g cup; best before 22/05/10), because the product contains undeclared sesame seeds.
• Food Safety Recall (France): Bonneterre recalls two varieties of Bonneterre brand Yaourt au Lait de Brebis (sheep milk yogurt), with a best before date of April 30, 2010, because the product may contain glass fragments.
• Food Safety Recall (France): Monoprix Bio recalls two varieties of Monoprix Bio brand Yaourt au Lait de Brebis (sheep milk yogurt), with a best before date of April 30, 2010, because the product may contain glass fragments.

Asia, Africa and the Pacific Islands

• OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls all non-expired lots of Children’s and Infants’ Tylenol, Motrin, Benadryl and Zyrtec liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait, because some of the products may not meet required quality standards. Please navigate to the live link for a list of recalled products.

Latin America and Caribbean

• OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls all non-expired lots of Children’s and Infants’ Tylenol, Motrin, Benadryl and Zyrtec liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait, because some of the products may not meet required quality standards. Please navigate to the live link for a list of recalled products.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket's recall web site.

• A&P
• Big Y® World Class Market®
  
• BJ's Wholesale Club, Inc.
  
• Bloom
  
• Brookshire's
  
• Costco Wholesale Corporation (US stores)
  
• Costco Wholesale Canada Ltd.
  
• EDEKA (Germany)
• Food City
  
• Food Lion
  
• Giant Food LLC
• Gros Cidac (Italy)
• Hannaford Brothers Co.
  
• Harris Teeter
  
• Harvey's Supermarket
  
• H-E-B
• The Kroger Company*
  
• Price Chopper
  
• Raley's
• Roundy's Supermarkets, Inc.
  
• Sainsbury's
  
• ShopRite
  
• Stop & Shop
• Sweetbay Supermarkets
• Target
  
• Top Food & Drug
• Tops Friendly Markets
  
• Wal-Mart Stores, Inc.
  
• Wegmans
  
• Whole Foods Market
  
• WinCo Foods
• Winn-Dixie Stores, Inc.
  

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.

Recall Roundup: January 15, 2010

Here is today's list of food safety recalls, product withdrawals and allergy alerts. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please click here or submit your request using the sidebar link.

United States

• OTC Pharmaceutical Recall: McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, recalls selected production lots of Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph Aspirin that may contain a chemical contaminant. The recalled items were distributed in the Americas, the United Arab Emirates, and Fiji.
• Allergy Alert: USDA posts updated retail consignee list for "Pepe's Gigante Louisiana Hot Sauce Flavored Cracklins," recalled several days ago due to the presence of undeclared milk protein.
• Food Safety Recall: Hines Nut Company recalls 270 packages of Pine Nuts, packaged under the brand name Harris Teeter Farmers Market. The Pine Nuts were purchased from Red River Foods in Camarillo, CA, and have the potential to be contaminated with Salmonella. The nuts were supplied only to Harris Teeter. Red River Foods is an importer of pine nuts from China, and operates a pine nut processing factory in Dalian, China.
• Food Safety Recall: PEO Chapter FO (Ashland, OR) recalls 75 - 1 lb packages of roasted hazelnuts, because they have the potential to be contaminated with Salmonella. The nuts were sold through the Victoria's and Strand's beauty salons in Ashland.
• Dietary Supplement Recall: MuscleMaster.com, Inc. recalls multiple production lots of seventeen dietary supplements due to FDA's concern that these products may contain steriods.
• Food Safety Recall: Parkers Farm, Inc. (Coon Rapids, MN) today expanded the previously announced recall of products to include all date codes because they have the potential to be contaminated with Listeria monocytogenes. Affected brands include Parkers Farm, Parkers, Happy Farms, Kroger, Central Markets, Dutch Farms, Crystal Farms, Heluva Good, Amish Classic, San Pablo, Century Resources, Block & Barrel, Cobblestone, Biery, and Dierks Waukesha. The recalled products were sold in retail stores nationwide.
• Food Safety Recall: Jerry Hayes Meats Inc. (Newark Valley, NY) recalls approximately 490 pounds of a beef carcass that may not have had the spinal column removed.
• Food Recall: Food City recalls Food City Fresh 2% Half Gallon Milk. No reason given for the recall.

Canada

• OTC Pharmaceutical Recall: McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, recalls selected production lots of Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph Aspirin that may contain a chemical contaminant. The recalled items were distributed in the Americas, the United Arab Emirates, and Fiji.
• Personal Care Product Safety Recall: Importers Farah Impex (Toronto, ON) and Gagan Foods International (Vancouver, BC), recall all lots of Hesh Aritha Powder, a powder shampoo, because of bacterial contamination. The recalled shampoo, a product of India, was sold in retail stores in Alberta, British Columbia, Manitoba and the Greater Toronto Area.

Europe

• Food Safety Notification (EU #2010.0041): Mercury in chilled swordfish fillets (Xiphias gladius) from Sri Lanka; distributed in Germany.
• Food Safety Notification (EU #2010.0042): Mercury in frozen blue shark (Prionace glauca) fillets from Spain; distributed in Italy.

Australia and New Zealand

• Allergy Alert: Dong Nam Trading recalls three Bravo brand ice cream products due to the presence of undeclared milk and peanuts. The recalled products were sold in Asian retail stores in New South Wales.

Asia, Africa & The Pacific

• OTC Pharmaceutical Recall (United Arab Emirates and Fiji): McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, recalls selected production lots of Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph Aspirin that may contain a chemical contaminant. The recalled items were distributed in the Americas, the United Arab Emirates, and Fiji

Latin America

• OTC Pharmaceutical Recall (North, Central and South America and the Caribbean region): McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, recalls selected production lots of Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph Aspirin that may contain a chemical contaminant. The recalled items were distributed in the Americas, the United Arab Emirates, and Fiji

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket's recall web site.

• A&P
• Big Y® World Class Market®
  
• BJ's Wholesale Club, Inc.
  
• Bloom
  
• Brookshire's
  
• Costco Wholesale Corporation (US stores)
  
• Costco Wholesale Canada Ltd.
  
• EDEKA (Germany)
• Food City
  
• Food Lion
  
• Giant Food LLC
• Gros Cidac (Italy)
• Hannaford Brothers Co.
  
• Harris Teeter
  
• Harvey's Supermarket
  
• H-E-B
• The Kroger Company*
  
• Price Chopper
  
• Raley's
• Roundy's Supermarkets, Inc.
  
• Sainsbury's
  
• ShopRite
  
• Stop & Shop
• Sweetbay Supermarkets
• Target
  
• Tops Friendly Markets
  
• Wal-Mart Stores, Inc.
  
• Wegmans
  
• Whole Foods Market
  
• Winn-Dixie Stores, Inc.
  

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.