Tylenol, Benadryl, Sudafed, Sinutab and Rolaids Recall

A new year has begun, but the product recalls continue at McNeil Consumer Healthcare, a troubled unit of Johnson & Johnson.

Tylenol is being recalled. Again.

Rolaids are being recalled. Also Again. We reported on the December recall in Antacid Alert: Rolaids Recall

McNeil is voluntarily recalling Tylenol 8 Hour, Tylenol Arthritis Pain, and Tylenol upper respiratory products, as well as Benadryl, Sudafed PE, and Sinutab products distributed in the U.S., the Caribbean, and Brazil. In addition, some Rolaids products are again being recalled.

These problems bring to mind an article that appeared in Fortune magazine in August: Why J&J’s headache won’t go away.

According to Fortune, Johnson & Johnson, the iconic maker of Band-Aids, has come under scrutiny from the U.S. Food and Drug Administration (FDA) as well as the U.S. Congress for a series of quality-control problems.

So you can find out about the details of the recall, including links to more information, we have included the release from the manufacturer below:

McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Over-The-Counter (OTC) Products

 

Fort Washington, PA (January 14, 2011) – In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. is voluntarily recalling, at the wholesale level, certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil. These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended. The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.
McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language “Does not meet USP” as required by regulation.

Both of these recalls are being initiated at the wholesale level. No action is required by consumers or healthcare providers and consumers can continue to use the product. These actions are not being undertaken on the basis of adverse events.

McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products. As previously announced, McNeil has been implementing a Comprehensive Action Plan at its U.S. manufacturing facilities to improve the quality systems 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.

Consumers can access full product details and other information about the recall on the www.mcneilproductrecall.com website or by calling our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time).

Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

Click Here for recall information on certain product lots of recalled products
Click Here to see frequently asked questions

Sources:

McNeil Consumer Healthcare

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