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Recall Observatory FDA recall evidence

Drug product

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.

D-1064-2013

August 08, 2013

Class II

Product summary

Firm
Marlex Pharmaceuticals, Inc.
Event
Event 65967
Status
Terminated
Classification
Class II
Quantity
28,387 bottles
Official record key
drug-enforcement:D-1064-2013

Official wording

Reason: 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.

Code information: Lot #: 3213, Exp 12/13

Distribution pattern: Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations