Medicines Were Made at Facility Where Cleaning Procedures Were Insufficient or Not Adequately Documented
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Reviewed By Laura J. Martin, MD
Jan. 18, 2011 -- McNeil Consumer Healthcare, which makes Tylenol pain relief drugs, says it is recalling a number of lots of its Tylenol products as well as some lots of Sinutab, Benadryl, and Sudafed PE because the medications were made at a plant where production was suspended in April 2010.
McNeil says in a news release posted on the FDA's web site that the recalled products were made in a Fort Washington, Pa., plant that was closed because of concerns about equipment cleaning procedures.
The company says it is voluntarily recalling the products at the wholesale level and that consumers do not need to take any action. The products can still be used by consumers, the statement says.
McNeil Recalling Tylenol and Other Products
McNeil Consumer Healthcare says it is recalling certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain, and Tylenol upper respiratory products. In addition, it says it is recalling certain lots of Benadryl, Sudafed PE, and Sinutab products that were distributed in the Caribbean and Brazil as well as in the United States.
"These products were manufactured at the McNeil plant ... prior to April 2010, when production at the facility was suspended," the McNeil statement says. "The company is initiating the recall as a precautionary measure after an extensive review of past product records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented."
Company Says Not Likely Recalled Drugs Are Impaired
The statement adds that "it is very unlikely that this impacted the quality of these products."
McNeil's statement says the company also has begun a voluntary recall of certain product lots of Rolaids Multi-Symptom Berry Tablets distributed in the U.S. in order to update the labeling. The labeling does not include the words "does not meet USP" as required by regulation, the statement says.
A USP label means the product meets standards of quality, purity, strength, and consistency of the United States Pharmacopeia, a non-governmental authority that sets standards for over-the-counter and prescription medications.
Marc Boston, a McNeil company spokesman, says 42,949,736 bottles and packages of Tylenol, Benadryl, Sudafed, and Sinutab are being recalled. Additionally, 3,924,168 bottles, rolls, and packages of Rolaids Multi-Symptom Berry Tablets are being recalled.
Quality Control Steps Being Taken by McNeil
The company says it has implemented a comprehensive action plan at its U.S. manufacturing facilities to improve quality at those sites.
"This product assessment is a key milestone in the implementation of that plan and the actions being undertaken as a result of the assessment are part of McNeil's ongoing commitment to ensure that all its products meet the high quality standards that consumers expect," the company statement says.
For more information, consumers can visit www.mcneilproductrecall.com or phone McNeil's consumer care center at 888-222-6036 from 8 a.m. to 8 p.m. Eastern time Monday through Friday and from 9 a.m. to 5 p.m. Eastern Saturday through Sunday.
The McNeil Consumer Healthcare Division of McNeil-PPC Inc. is a Johnson & Johnson Company.
SOURCE: News release, McNeil Consumer Healthcare.
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