Recall -- Firm Press Release
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.
Magno-Humphries, Inc. voluntarily recalls one lot of Dixon's®,
Acetaminophen 325 mg Analgesic, 100 Tablet bottles
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's®, 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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Source:
FDA Release: http://www.fda.gov/oc/po/firmrecalls/magno12_03.html
