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U.S. Department of Health and Human Services

Enforcement Report - Week of October 9, 2013

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Product Detail

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.
Recall Number D-1064-2013
Classification Class II
Code Info Lot #: 3213, Exp 12/13
Product Distributed Qty 28,387 bottles
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.

Event Detail

Event Id 65967
Product Type Drugs
Status Ongoing
Recalling Firm Marlex Pharmaceuticals, Inc.
City New Castle
State DE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.