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Tuesday, October 19, 2010

New Tylenol Recall Issued

Continuing in a long string of drug recalls, Johnson & Johnson subsidiary McNeil yesterday issued a recall for another Tylenol product. The recall focuses on Tylenol 8 hr caplets 50 count packages. The McNeil website shows seven other recent recalls, including:

  • Tylenol Extra Strength and Tylenol PM
  • Benadryl Allergy Ultratab
  • Motrin IB
  • Children's Tylenol, Infatns' Tylenol, and Children's Tylenol Meltaways
  • Chidren's Motrin and Infants' Motrin
  • Children's Zyrtec
  • Children's Benadryl

In the current Tylenol recall, the defective drugs are being recalled largely due to a contaminating odor, similar to that responsible for a number of other recalls. A statement from McNeil said the "risk of adverse medical events is remote," the exact language it has used about previous recalls. However, investigation of reports of serious injuries due to Tylenol related to previous recalls is still ongoing. According to the FDA, nearly 800 reports of serious side effects associated with these recalls have been received.

Although these adverse events have not all officially been linked to the recalled Tylenol, Motrin, and Benadryl, an FDA inspection of a McNeil plant in Connecticut recently revealed a number of shocking violations of FDA standards. These violations included not just missing record and failure to follow-up on potentially anomalous batches of medication, but even the failure to establish "scientifically sound and appropriate test procedures designed to assure [sic?] that drug products conform to appropriate standards of identity, strength, quality, and purity." The list also includes a failure to provide proper instructions for the cleaning and maintenance of equipment and, not surprisingly, a failure to properly clean and maintain equipment.

With these defects in manufacturing, it would not be surprising if the highly odiferous 2,4,6-tribbomoanisole (TBA) were only the most olfactory sign of a more serious contamination.

If you or a loved one has suffered a serious injury as a result of contaminated batch of Tylenol, Motrin, or Benadryl, the product liability lawyers of The Cochran Firm may be able to help you get compensation. To learn more, please contact us today for a free initial consultation.


UPDATE: McNeil has confirmed that the over 125,000 units involved in Monday's recall were in fact made at the Fort Washington plant with the poor inspection report cited above. In addition, a spokesman for McNeil said that although there were a number of adverse events reported, only one of them was associated with the odor itself, lending credibility to the theory that other, subtler contamination may also be present in the tainted Tylenol.

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posted by Benjamin A. Irwin at 12:08 PM

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