McNeil Consumer Healthcare has expanded a recall of its OTC medications to include 21 additional lots. McNeil said in a July 8 news release(www.fda.gov) posted on the FDA website that 21 lots were added to its recall list as a precautionary measure after a review determined that some packaging materials used in those lots had been shipped and stored on the same type of wooden pallet tied to the presence of 2,4,6-tribromoanisole in earlier recalled lots.
McNeil said it has stopped accepting shipments of materials from its suppliers on that type of pallet.
In January, McNeil recalled more than 500 lots of its OTC products -- including Benadryl, Rolaids, multiple formulations of both Motrin and Children's Motrin, and numerous formulations of Tylenol and Children's Tylenol -- following consumer complaints of moldy, musty or mildew-like odor.
The smell was linked to trace amounts of a chemical called 2,4,6-tribromoanisole, a degradant of 2,4,6-tribromophenol, which is a fungicide and flame retardant used to treat wooden pallets.
The manufacturer expanded the recall in June(www.fda.gov) to include products it said were inadvertently omitted from the initial action.
A complete list of the 21 lots in the current recall is included in the July 8 news release.
Consumers who purchased products from the recalled lots should stop using the products and contact McNeil for instructions on receiving a refund or replacement, the manufacturer said.
Adverse reactions to the products may be reported to the FDA’s MedWatch Program(www.fda.gov).
On April 30, McNeil recalled more than 40 formulations of its children's and infants' allergy and pain relief products because of manufacturing deficiencies that could affect their quality, purity or potency. The company announced June 24 that those products will not return to the market(www.jnj.com) before the end of the year.
The FDA announced in May that it is conducting a company-wide investigation of McNeil's manufacturing practices.