McNeil recalls several over-the-counter medications
U.S. Food and Drug AdministrationJanuary 18, 2011, 9:57am 2,315 views | Post a comment
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.mcneilproductrecall.com
• 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
Your Opinions and Comments
Be the first to comment on this story!
You must be logged in to post a comment.
Breaking News Archives
AgriLife Extension to offer programs on Zika, mosquito management in SA (August 24, 2016)
Falls City plans early release for Bruni game Aug. 26 (August 23, 2016)
Most Wanted Fugitive Captured in San Antonio (August 23, 2016)
Watch for signal lights at Standish and Fourth streets (August 23, 2016)
Filing deadline Aug. 25 for Floresville council Place 3, today for other offices (August 22, 2016)
Nixon-Smiley CISD closed first day of school (August 22, 2016)
Rain totals for the week (August 22, 2016)
Overnight flooding causes widespread damage in Wilson County; emergency... (August 21, 2016)
Shelter for flood victims open in Floresville (August 21, 2016)
Poth football scrimmage moved (August 18, 2016)
Counterfeit $20 bills spotted in Floresville (August 17, 2016)
DPS Reminds Drivers to Obey Traffic Laws, Watch For Children As New School... (August 17, 2016)
Weather moves Falls City Aug. 18 scrimmage (August 17, 2016)
Johnny Garcia: One of Texas 10 Most Wanted Fugitives (August 16, 2016)
Flash flood watch issued (August 15, 2016)
Local rain reports (August 15, 2016)
Authorities seek information on vehicle theft (August 11, 2016)
Texas Rangers arrest Nixon city manager (August 11, 2016)
What’s going on? Floresville Police Department closed (August 11, 2016)
Floresville Event Center fire-suppression system fails inspection; city... (August 10, 2016)
Venue change for Rancho de las Cabras film (August 10, 2016)
Police arrest suspect in Nixon armed robbery (August 3, 2016)
Prescribed Burn Planned for Government Canyon State Natural Area Wednesday (August 2, 2016)