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Registered: 03-19-2003
Tue, 01-19-2010 - 7:59am
Safety Alert: Voluntary Recall

McNeil Consumer Healthcare Voluntarily Recalls Certain Over-The-Counter (OTC) Products Manufactured in the U.S. and Other Countries.

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare has voluntarily recalled certain lot numbers following an investigation of consumer reports of an unusual moldy, musty, or mildew-like odor. The odor was associated with temporary, non-serious gastrointestinal symptoms, including nausea, stomach pain, vomiting, and/or diarrhea.

This recall expands an earlier recall of acetaminophen 100-count bottles with EZ open caps labeled Tylenol Arthritis that began in late 2009. Some of the medications included in this expanded recall are used in the treatment of pain, like:

  • Children’s Motrin

  • Children’s Meltaway Tylenol

  • Benadryl

  • Extra Strength Tylenol

  • Regular Strength Tylenol

  • Motrin IB

  • Rolaids

  • St. Joseph Aspirin

  • Tylenol 8 hour

  • Specific lot numbers affected by this recall can be found at http://www.mcneilproductrecall.com/

    To find if you are in possession of any of the affected products, look on the side of the bottle label for the lot number.

    Individuals who may have ANY of these lots in their possession should:

  • Stop taking the medication.
  • Contact your healthcare provider if you have recently taken any of these medications and are experiencing symptoms as listed above or have medically-related questions.
  • Report any adverse reactions to the FDA’s MedWatch Program by:
  • Fax: 1-800-FDA-0178,

  • Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

  • Internet: www.fda.gov/medwatch (Medwatch website)

  • Contact McNeil Consumer Healthcare for instructions if you wish to obtain replacement medications or a refund and also to receive information about safe disposal of these products.

  • The public may direct questions to McNeil Consumer Healthcare at www.mcneilproductrecall.com or 1-888-222-6036 (Monday-Friday, 8:00 a.m. to 10:00 p.m. Eastern time and Saturday-Sunday 9:00 a.m. to 5:00 p.m. Eastern time).