More quality issues dog J&J
pharmafile | May 5, 2010 | News story | Manufacturing and Production | Johnson & Johnson, manufacturing compliance, recalls
Johnson & Johnson’s manufacturing is under the spotlight at the FDA once again for quality issues affecting its products.
At the US regulator’s request, the drugmaker is recalling 43 over-the-counter medicines for infants and children made by its McNeil Consumer Healthcare division and distributed in the US and several other markets in the Americas and Middle East.
According to the recall information released by McNeil, some of the products may contain a higher concentration of active ingredient than specified, while others may contain excipients that do not meet quality standards. In addition, other products may be contaminated with tiny particles.
The drugs being recalled included various flavors of the antihistamine Zyrtec (cetirizine), cough medicine Benadryl (diphenydramine), painkiller Motrin (ibuprofen) and a number of Tylenol (acetaminophen) formulations including liquids, drops and plus.
More than 1,500 lots are affected, equating to hundreds of thousands of bottles in medicine cabinets and pharmacy shelves.
The FDA said it asked for the recall after an inspection of a J&J facility in Fort Washington, Pennsylvania, earlier this month uncovered the quality compliance issues, which are said to extend back in time.
The recall comes after McNeil was forced to recall Tylenol Arthritis Pain caplets which were contaminated with a trace chemical originating from the wooden pallets used to transport and store the product, as well as other incidents involving Tylenol’s primary product packaging and illegible labelling in recent weeks.
J&J insists that the recall is voluntary, and a precautionary measure that does not result from any reported adverse events.
And that position is backed up by FDA commissioner Margaret Hamburg, who says in a statement that “the potential for serious health problems is remote”.
“We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product,” she said, adding: “Americans deserve medications that are safe, effective and of the highest quality.”
The FDA is continuing to look into the issue, however, raising the possibility that J&J could find itself facing regulatory action if it cannot set its house in order soon.
“We are investigating the products and facilities associated with this recall and will provide updates as we learn more,” said Hamburg.
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