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Class II: temporary or reversible health riskTerminated

Allergan Sales Tazorac Recall

Tazorac (tazarotene) Gel 0

Allergan Sales, LLC · Waco, TX

Risk level
Class II
Reported by FDA
Jul 13, 2016
Recall ID
D-1064-2016
Check your lot numberHow we source this data

Summary

Allergan Sales recalled Tazorac starting May 10, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1064-2016 on Jul 13, 2016. Reason: Failed Content Uniformity Specifications. Status: Terminated.

Why it was recalled

Failed Content Uniformity Specifications.

Product description

Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612

Lot numbers, UPCs & expiration codes

Lot #: a) 84172, b) 84173, Exp FEB/2017

Where it was sold

Nationwide and Puerto Rico

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-1064-2016
Classification
Class II
Status
Terminated
Recall initiated
May 10, 2016
FDA report date
Jul 13, 2016
Quantity
17802 units
Recall type
Voluntary: Firm initiated
Recalling firm
Allergan Sales, LLC

Original FDA data

Every field from FDA enforcement report D-1064-2016, exactly as published.

Show all FDA fields
City
Waco
State
TX
Status
Terminated
Country
United States
Event ID
74126
Address
8301 Mars Dr
Code information
Lot #: a) 84172, b) 84173, Exp FEB/2017
Postal code
76712-6578
Report date
Jul 13, 2016
Product type
Drugs
Recall number
D-1064-2016
Classification
Class II
Recalling firm
Allergan Sales, LLC
Product quantity
17802 units
Termination date
Dec 6, 2017
Reason for recall
Failed Content Uniformity Specifications.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
May 10, 2016
Initial firm notification
Letter
Center classification date
Jul 6, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1064-2016, published Jul 13, 2016. 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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