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Class III: unlikely to cause harmTerminated

Taro Pharmaceuticals U.S.A. Clobetasol Propionate Cream Recall

Clobetasol Propionate Cream USP, 0

Taro Pharmaceuticals U.S.A., Inc. · Hawthorne, NY

Risk level
Class III
Reported by FDA
Feb 7, 2018
Recall ID
D-0249-2018
Check your lot numberHow we source this data

Summary

Taro Pharmaceuticals U.S.A. recalled Clobetasol Propionate Cream starting Dec 21, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0249-2018 on Feb 7, 2018. Reason: Failed Content Uniformity Specifications. Status: Terminated.

Why it was recalled

Failed Content Uniformity Specifications

Product description

Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3

Lot numbers, UPCs & expiration codes

Lot 311235, exp Sept 2018

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-0249-2018
Classification
Class III
Status
Terminated
Recall initiated
Dec 21, 2017
FDA report date
Feb 7, 2018
Quantity
27,792 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Taro Pharmaceuticals U.S.A., Inc.

Original FDA data

Every field from FDA enforcement report D-0249-2018, exactly as published.

Show all FDA fields
City
Hawthorne
State
NY
Status
Terminated
Country
United States
Event ID
79029
Address
3 Skyline Dr
Code information
Lot 311235, exp Sept 2018
Postal code
10532-2174
Report date
Feb 7, 2018
Product type
Drugs
Recall number
D-0249-2018
Classification
Class III
Recalling firm
Taro Pharmaceuticals U.S.A., Inc.
Product quantity
27,792 tubes
Termination date
Sep 21, 2020
Reason for recall
Failed Content Uniformity Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
Distribution pattern
Nationwide
Recall initiation date
Dec 21, 2017
Initial firm notification
Letter
Center classification date
Feb 1, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0249-2018, published Feb 7, 2018. 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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