Reported Oct 9, 2013 · Terminated

Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720,…

Marlex Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Marlex Pharmaceuticals, Inc. · 50 McCullough Dr · New Castle, DE · 19720-2066

Is this the product you have?

    • Acetaminophen Tablets
    • 500 mg
    • 100-count bottles
  • Distributed byMarlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8
Lot codes and dates
    • Lot #: 3213
    • Exp 12/13
Amount recalled
28,387 bottles

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 20, 2014 · Data as of Sep 19, 7:58 PM UTC

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