McNeil Consumer Healthcare, part of Johnson & Johnson is voluntarily recalling specific lots of Tylenol upper respiratory medications, Tylenol Arthritis Pain, Benadryl, Sinutab and Sudafed PE, at wholesale level and distributed in the USA, Brazil and the Caribbean. They were all manufactured at the company’s Fort Washington, PA, plant before April 2010 when production was halted.
In consultation with the FDA (Food and Drug Administration, USA), McNeil Consumer Healthcare says the recall is a precautionary measure following a comprehensive review of production records which detected flaws in the equipment cleaning procedures. The company also adds that the documentation of that cleaning was inadequate.
The company says the quality of these products is not likely to be affected.
Because of a labeling update requirement, the company is also voluntarily recalling specific lots of Rolaids Multi-Symptom Berry Tablets which were distributed in the USA. According to an FDA communiqué, the product labeling “does not include the language ‘Does not meet USP’ as required by regulation.”
Consumers and health care professionals and providers can continue to use the products and do not need to take any action – the recalls are directed at the wholesale level only.
McNeil Consumer Healthcare emphasized that “These actions are not being undertaken on the basis of adverse events.”
According to an FDA communiqué, McNeil is currently executing a Comprehensive Action Plan at its manufacturing plants throughout the USA to improve quality systems.
McNeil Consumer Healthcare wrote:
“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.”
This recall represents nearly 47 million units of OTC (over-the-counter) medications.
Johnson & Johnson has issued several recalls of non-prescription (OTC) medicines since the last quarter of 2009, because of a variety of problems, including bits of floating metal specs and excessive concentrations of active ingredients. They have cost the company a lot of money, as well as a US Justice Department criminal probe.
According to the Wall Street Journal, Johnson & Johnson shares dropped 36 cents yesterday to $62.55.
Johnson & Johnson Chairman and CEO Bill Weldon said:
“Steps we have taken under the Comprehensive Action Plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil. They help us assure that moving forward, any of our products in the marketplace live up to the trusted standards and expectations that consumers have for all products coming from a Johnson & Johnson company, anywhere in the world.”
“Product Recall Information” (McNeil Consumer Healthcare)
People can also contact the company’s Consumer Care Center at 1-888-222-6036 (Monday to Friday, 8am to 8pm, and Saturday/Sunday 9am to 5pm – Eastern Time)
The FDA asks health care professionals and consumers to report any adverse event to its
Sources: McNeil Consumer Healthcare, FDA, Wall Street Journal
Written by Christian Nordqvist