CORRECTING and REPLACING Medline Industries, Inc. Issues a Voluntary Nationwide Recall of One Lot of Acetaminophen Tablets, 500mg, Due to Mislabeling with Incorrect Strength

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MUNDELEIN, Ill.–(BUSINESS WIRE)–Fourth paragraph, first sentence of release should read: Consumers with
questions regarding this recall can contact Medline Industries,
Inc. by phone 866-359-1704 or recalls@medline.com
Monday through Friday between the hours of 8am and 5pm CT. (instead of
Consumers with questions regarding this recall can contact Medline
Industries, Inc. by phone 866-767-1704 or recalls@medline.com
Monday through Friday between the hours of 8am and 5pm CST.)

The corrected release reads: 

MEDLINE INDUSTRIES, INC. ISSUES A VOLUNTARY NATIONWIDE RECALL OF ONE
LOT OF ACETAMINOPHEN TABLETS, 500MG, DUE TO MISLABELING WITH INCORRECT
STRENGTH

Medline Industries, Inc. announced that it will initiate a voluntary
nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg,
uncoated compressed tablets to the consumer level. The Acetaminophen
500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying
“Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The
Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets.
This error is not easily identifiable by the user or prescriber. If the
product is taken at the maximum labeled dose, every four hours, five
doses a day, or with other medications containing acetaminophen, it may
lead to liver toxicity or liver failure. To date, Medline Industries,
Inc. has not received any reports of adverse events associated with this
product.

Acetaminophen tablets is an over the counter (OTC) oral medication used
to temporarily relieve minor aches and pains due to minor pain of
arthritis, muscular aches, back aches, headaches, toothaches, the common
cold, premenstrual and menstrual cramps, and reduces fever. This item is
packaged as 100 tablets per bottle, Medline Item Number: OTC20101, NDC#:
53329-641-30. The recalled Acetaminophen 500mg, Tab 100/BT (OTC20101)
includes lot # 45810 with expiration date May 2018.

This lot was distributed nationwide from June 12, 2015 through September
18, 2015. Medline Industries, Inc. is investigating to determine the
root cause and corrective and preventative actions. Medline Industries,
Inc. notified its distributors, consumers and/or retailer customers
by First Class Mail on September 25th, 2015 and is
arranging for return and credit of all recalled products. Consumers,
distributors, and/or retailers that have product which is being recalled
should stop using and return to Medline Industries, Inc.

Consumers with questions regarding this recall can contact Medline
Industries, Inc. by phone 866-359-1704 or recalls@medline.com
Monday through Friday between the hours of 8am and 5pm CT. Consumers
should contact their physician or healthcare provider if they have
experienced any problems that may be related to taking or using this
drug product.

Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA’s MedWatch Adverse Event Reporting
program either online, by regular mail or by fax.

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

Contacts

Medline Industries, Inc.
Kathy Cummings, 847-643-3308
KCummings@medline.com