Navigation Links
McNeil Consumer Healthcare Announces Voluntary Recall of One Product Lot of TYLENOL® 8 Hour Caplets 50 Count Sold in the United States and Puerto Rico

FORT WASHINGTON, Pa., Oct. 18 /PRNewswire/ -- McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling one product lot of TYLENOL® 8 Hour caplets 50 count bottles to the retail level.  McNeil is taking this action following a small number of complaints of a musty or moldy odor.  The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called  2,4,6-tribromoanisole.  This voluntary action is being taken as a precaution and the risk of adverse medical events is remote.  To date, observed events reported to McNeil for this lot were temporary and non-serious.

The product lot number for the recalled product can be found on the side of the bottle label.



3 0045-0297-51 8 Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.  

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:
  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178

  • This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

    CONSUMER INQUIRIES:1-888-222-6036

    SOURCE McNeil Consumer Healthcare
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Announces Oncology Research Collaboration Agreement with the Koch Institute for Integrative Cancer Research at MIT
    2. The Pittsburgh Life Sciences Greenhouse Congratulates Diamyd Medical on Its Agreement with Ortho-McNeil-Janssen Pharmaceuticals to Develop Diabetes Therapy
    3. Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax and is Sentenced to Criminal Fine of $6.14 Million
    4. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Resolves Investigation of Past TOPAMAX(R) Marketing and Promotional Activities
    5. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Agrees to $75 Million Settlement for Topamax(R) False Claims Lawsuit
    6. McNeil Consumer Healthcare Announces a Voluntary Nationwide Recall of All Lots of TYLENOL(R) Arthritis Pain 100 Count With EZ-OPEN CAP
    7. AUDIO from Medialink and Ortho-McNeil-Janssen Pharmaceuticals Inc.: Getting Ready for Cold and Flu Season
    8. McNeil Consumer Healthcare Announces Voluntary Recall of Certain Lots of TYLENOL(R) Arthritis Pain 100 Count with EZ-OPEN CAP
    9. Arena Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Type 2 Diabetes Drug Candidate in Partnership with Ortho-McNeil-Janssen Pharmaceuticals
    10. Isis Earns $5 Million Milestone Payment From Ortho-McNeil, Inc. for Initiation of Phase 1 Study of ISIS 325568
    11. FDA Consumer Health Information - FDA Tightens Reins on Unapproved Chelation Drugs
    Post Your Comments:
    (Date:11/25/2015)... , Nov. 25, 2015 On Tuesday, ... federal bellwether trial against Wright Medical Technology, Inc. ... their Conserve metal-on-metal hip implant device, awarded $11 ... a two week trial and three days of ... hip device was defectively designed and unreasonably dangerous, ...
    (Date:11/25/2015)... Nov. 25, 2015  Henry Schein, Inc., the world,s ... office-based dental, medical and animal health practitioners, will unveil ... Henry Schein ConnectDental® Pavilion , which brings together ... open solutions designed to help any practice or laboratory ... for a schedule of experts appearing at the ...
    (Date:11/25/2015)... 2015 Allergan plc (NYSE: AGN ) today ... New York State Attorney General,s Office to ... and other statutes with the Attorney General over the decision ... marketing and selling the now generic version of memantine immediate ... liability, has released its counterclaims against New York ...
    Breaking Medicine Technology:
    (Date:11/27/2015)... ... 2015 , ... Consistent with the Radiology Business Management ... Radiology Marketing Programs meeting will showcase some of the best 2015 radiology ... Palace in Las Vegas with a pre-conference session on a collaborative approach for ...
    (Date:11/27/2015)... Minn. (PRWEB) , ... November 27, 2015 , ... ... start failing. Secura Consultants has prided itself for not only fulfilling the needs ... income protection solutions at an affordable price and providing top-tier customer service. However, ...
    (Date:11/27/2015)... , ... November 27, 2015 , ... ... largest, most successful and prominent nonprofit healthcare organizations in the country. They have ... with various organizations, and helped advance the healthcare industry as a whole through ...
    (Date:11/27/2015)... ... , ... Indosoft Inc., developer and distributor of the world-class ... (Long Term Support) into its Q-Suite 5.10 product line. , Making the change ... version of Asterisk that will receive not only security fixes, but feature and ...
    (Date:11/26/2015)... ... November 26, 2015 , ... CognisantMD ... for diagnostic imaging in the Waterloo region. Using the Ocean Platform, family physicians ... directly from their electronic medical record (EMR) without the need for redundant patient ...
    Breaking Medicine News(10 mins):