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:
FDA also noted,
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.
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