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Class II: temporary or reversible health riskTerminated

Marlex Pharmaceuticals Acetaminophen Tablets Recall

Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceutical…

Marlex Pharmaceuticals, Inc. · New Castle, DE

Risk level
Class II
Reported by FDA
Oct 9, 2013
Recall ID
D-1064-2013
Check your lot numberHow we source this data

Summary

Marlex Pharmaceuticals recalled Acetaminophen Tablets starting Aug 8, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1064-2013 on Oct 9, 2013. 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. Status: Terminated.

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.

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.

Lot numbers, UPCs & expiration codes

Lot #: 3213, Exp 12/13

Where it was sold

Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1064-2013
Classification
Class II
Status
Terminated
Recall initiated
Aug 8, 2013
FDA report date
Oct 9, 2013
Quantity
28,387 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Marlex Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-1064-2013, exactly as published.

Show all FDA fields
City
New Castle
State
DE
Status
Terminated
Country
United States
Event ID
65967
Address
50 McCullough Dr
Address (line 2)
Southgate Industrial Park
Code information
Lot #: 3213, Exp 12/13
Postal code
19720-2066
Report date
Oct 9, 2013
Product type
Drugs
Recall number
D-1064-2013
Classification
Class II
Recalling firm
Marlex Pharmaceuticals, Inc.
Product quantity
28,387 bottles
Termination date
Nov 20, 2014
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.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide.
Recall initiation date
Aug 8, 2013
Initial firm notification
Letter
Center classification date
Sep 27, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1064-2013, published Oct 9, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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