Recall of Tylenol, Benadryl, Sudafed, Sinutab Issued Over Sanitary Problems
Johnson & Johnson has issued another recall involving Tylenol, Benadryl, Sudafed and Sinutab over-the-counter (OTC) drugs after finding that equipment at a McNeil Healthcare manufacturing plant where the drugs were made was not cleaned properly.
The Johnson & Johnson OTC drug recall was announced by the FDA on January 14. The drugs were all manufactured at the Fort Washington, Pennsylvania, manufacturing plant before it was shut down by federal drug safety officials last year for quality control problems. Those problems led to a massive recall of 40 different liquid medications, including Motrin, Tylenol, Benadryl and Zyrtec; many of which were for children.
The latest drug recall affects a number of lots of Tylenol allergy, cold and sinus cool burst caplets, Tylenol arthritis pain geltabs, Tylenol 8-hour caplets, Benadryl allergy kapgels and caplets, Sudafed PE caplets, and Sinutab Sinus caplets. All of those drugs have been recalled following a review of production records at the Ft. Washington plant, which revealed that equipment cleaning procedures were inadequate or were not adequately documented.
The recall is taking place at the wholesale level and the company claims that it is unlikely that the quality of the drugs was actually impacted. The drugs were all made at the plant prior to the shutdown.
In addition, Johnson & Johnson is also recalling some lots of Rolaids Multi-Symptom berry tablets in order to update the labeling so that it meets regulatory standards.
A full list of all of the recalled drugs and their lot numbers can be found attached to the McNeil Healthcare press release.
This latest round of recalls comes about a month after the FDA released Fort Washington inspection reports. Inspectors found a number of problems at the facility that included poor quality control measures, and inadequate and sometimes disjointed tracking and responses to consumer complaints.
It also comes just days after Oregon’a attorney general filed a lawsuit against Johnson & Johnson claiming that the company had conducted a ‘phantom’ Motrin recall in 2008 by hiring contractors to buy out the supply of drugs from every store, instead of announcing that there had been defective batches of the drug released to the public.
In addition, there have been at least two other Johnson & Johnson class action lawsuits filed against the company over a string of recalled drugs in 2010, accusing it of fraud and racketeering.
Jan 19, 2011