Tylenol, Benadryl and Rolaids Recalled for Production and Label Problems

more mcneil products recalledMillions of packages of Tylenol, Benadryl, Sudafed and Sinutab products are being recalled by manufacturer Johnson & Johnson's McNeil Consumer Healthcare due to questions about machine cleanliness and when the over-the-counter medicines were made.

A recall of certain lots of Rolaids Multi-Symptom Berry Tablets over a labeling issue was also announced, the U.S. Food and Drug Administration said.

McNeil said consumers don't have to do anything for these recalls, that consumers can continue to use the products and that the action is "not being undertaken on the basis of adverse events." The company didn't know when the products would be back on store shelves.McNeil has recalled several popular brand-name products since 2009, when consumer complaints of a foul, moldy odor were tracked to a chemical used on wooden pallets that stored packing material for medicines.

In the most current recall, McNeil said certain lots of the following medications are affected:
  • Tylenol 8 Hour
  • Tylenol Arthritis Pain
  • Benadryl
  • Sudafed PE
  • Various Tylenol cold and allergy products
  • Various Sinutab products
Those products -- sold nationwide, and in the Caribbean and Brazil -- were made at the McNeil plant in Fort Washington, Pa. before its closing in April 2010. McNeil has listed the lot numbers of recalled medication.

McNeil reviewed production records and found insufficient equipment cleaning or records of it, triggering this latest recall. The company said it "is very unlikely that this impacted the quality of these products."

The review is part of a quality program McNeil put in place at its U.S. plants, according to the FDA. The once-venerated Tylenol brand of pain medication and other McNeil drugs have been recalled a half-dozen times since December 2009. A recall of other products including Motrin has led to an FDA investigation and a lawsuit brought by the Oregon Attorney General.

In the Rolaids recall, the company said the labels don't have "does not meet USP" on them. That stands for United States Pharmacopeia, a non-governmental testing method. Though the FDA doesn't require the testing on medicines, it does require drug makers to label medicines that don't use it, McNeil said.

Consumers with questions about the products should call McNeil at (888) 222-6036 from 8 a.m. to 8 p.m. Eastern, Monday through Friday or 9 a.m. to 5 p.m. Eastern on Saturdays and Sundays. Consumers with medical questions should talk to their doctor.

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happenings

So for a Rolaids Recall to happen the FDA has to find it first and them McNeil says "consumers don't have to do anything for these recalls, that consumers can continue to use the products and that the action is "not being undertaken on the basis of adverse events." Sounds to me there isn't much punishment just a simple Tylenol, Benadryl and Rolaids recall and sweep everything under the rug.

December 20 2011 at 7:41 PM Report abuse rate up rate down Reply
richardstances

I have to say it is so important for the FDA to be very strict when it comes to recalls. I have heard a lot about Tylenol, Benadryl and Rolaids recalls and it makes me nervous every time I purchase any medicine. Now that I have kids I pay even more attention to these issues. I personally have used Rolaids for years and I am a big fan. I have never had any issues with Rolaids at all. That being said I will still listen when I hear about recalls. I was just checking out this Rolaids Recall website the other day - http://www.rolaidsrecall.com. It can be argued that some Rolaids recalls have not been completely fair but I understand the need to be safe rather than sorry.

December 14 2011 at 12:42 PM Report abuse rate up rate down Reply