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
- Sudafed PE
- Various Tylenol cold and allergy products
- Various Sinutab products
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.