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FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Contact:
Doris Meade
Regulatory Affairs
(503) 684-5464 x153
FOR IMMEDIATE RELEASE -- Tigard, OR -- December 4, 2003 -- Magno-Humphries, Inc., Tigard, Oregon, is voluntarily recalling one lot consisting of 504 bottles of Dixon'sŪ, APAP Acetaminophen 325 mg Analgesic Tablets, an over-the-counter drug product sold in 100 Tablet bottles with lot number 319687, Expiration Date 03/05.
The recall is effective immediately and is being undertaken because this lot contains an excess of the labeled amount of acetaminophen. The tablets contained in the mislabeled bottles are 500 mg Acetaminophen, instead of 325 mg Acetaminophen. The acetaminophen is being recalled because overdoses of acetaminophen can lead to severe health problems including liver toxicity and liver failure. The acetaminophen was sold under the Dixon's® label at retail stores and pharmacies nationwide beginning in August 2003.
Consumers who purchased bottles with lot number 319687 are urged to discontinue use of the product immediately and return it to the place of purchase for a full refund. Consumers with questions may contact Magno-Humphries, Inc., at 1-800-935-6737.
This recall is being made in cooperation with the U.S. Food and Drug Administration. To date, no consumer complaints have been reported.
Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
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