Home / Recalls / Marlex Pharmaceuticals, Inc. / D-1064-2013

D-1064-2013 Class II Terminated

Recalled by Marlex Pharmaceuticals, Inc. — New Castle, DE

Recall Details

Product Type: Drugs
Report Date: October 9, 2013
Initiation Date: August 8, 2013
Termination Date: November 20, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28,387 bottles

Product Description

Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.

Reason for Recall

CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.

Distribution Pattern

Nationwide.

Code Information

Lot #: 3213, Exp 12/13