Medline Industries has announced its voluntary nationwide recall of a lot of its Acetaminophen (acetaminophen) tablets due to labeling with incorrect strength.
According to the company’s statement published by the U.S. Food and Drug Administration (FDA), the recalled 500mg products were incorrectly labeled as 325mg tablets.
The tablets affected by the recall belong to lot number 45810. These are 500mg uncoated, compressed Acetaminophen tablets, with Medline item number OTC20101 printed on and an expiration date of May 2018. The affected products come in 100-tablet bottles and were distributed across the United States from June 12 to Sept. 18, 2015.
The statement warned that when taken at the maximum labeled dose every four hours at five doses per day, or with other drugs that contain acetaminophen, liver toxicity or liver failure may take place.
Medline Industries, however, said they have not received any report of such adverse reaction linked to the mislabeled products.
It added that the error is not easily detected by users and health care providers.
An over-the-counter (OTC) medication, acetaminophen is taken orally for the temporary relief of muscle aches, back aches, headaches, toothaches, minor arthritis pain, pre-menstrual and menstrual cramps and the common cold. It is also used for reducing fever.
Acetaminophen users are encouraged to call their doctor once they experience nausea, upper stomach pain, itching, appetite loss, dark urine or jaundice.
Taking the drug is not recommended without a physician’s advice if one has had cirrhosis or alcoholic liver disease, or if consuming over three alcoholic beverages a day. Alcohol consumption is also discouraged during drug therapy due to the risk of liver damage.
The FDA said that Medline Industries had notified consumers, distributors and retailers by First Class Mail on Sept. 25, and is arranging for the return and credit of all affected products. The pharmaceutical firm is currently investigating the root cause of the mislabeling and the necessary corrective and preventive measures.
Affected consumers may contact Medline Industries by calling 866-359-1704 or sending an email to firstname.lastname@example.org Monday to Friday between 8 am and 5 pm CST. They are also urged to consult their physician if they have experienced anything that may be related to using this drug.
For adverse reactions or quality concerns relating to Acetaminophen, one may report to the MedWatch Adverse Event Reporting program of the FDA by:
- Completing and submitting an online report: www.fda.gov/medwatch/report.htm.
- Mailing or sending fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
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