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Class II: temporary or reversible health riskTerminated

Actavis Elizabeth Alprazolam Orally Disintegrating Tablets Recall

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG

Actavis Elizabeth LLC · Elizabeth, NJ

Risk level
Class II
Reported by FDA
Dec 4, 2013
Recall ID
D-018-2014
Check your lot numberHow we source this data

Summary

Actavis Elizabeth recalled Alprazolam Orally Disintegrating Tablets starting Oct 9, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-018-2014 on Dec 4, 2013. Reason: Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets. Status: Terminated.

Why it was recalled

Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

Product description

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

Lot numbers, UPCs & expiration codes

Lot # 59380831, Exp. May 2014

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-018-2014
Classification
Class II
Status
Terminated
Recall initiated
Oct 9, 2013
FDA report date
Dec 4, 2013
Quantity
756 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Actavis Elizabeth LLC

Original FDA data

Every field from FDA enforcement report D-018-2014, exactly as published.

Show all FDA fields
City
Elizabeth
State
NJ
Status
Terminated
Country
United States
Event ID
66528
Address
200 Elmora Ave
Code information
Lot # 59380831, Exp. May 2014
Postal code
07202-1106
Report date
Dec 4, 2013
Product type
Drugs
Recall number
D-018-2014
Classification
Class II
Recalling firm
Actavis Elizabeth LLC
Product quantity
756 bottles
Termination date
Nov 3, 2014
Reason for recall
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Voluntary / mandated
Voluntary: Firm initiated
Product description
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
Distribution pattern
Nationwide
Recall initiation date
Oct 9, 2013
Initial firm notification
Letter
Center classification date
Nov 22, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-018-2014, published Dec 4, 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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