Why it was recalled
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Product description
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
Lot numbers, UPCs & expiration codes
a) AB28353, Exp 12/31/2021; b) AB40178, Exp 12/31/2021
Where it was sold
Nationwide in the U.S.
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-1496-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 20, 2020
- FDA report date
- Aug 19, 2020
- Quantity
- 7632 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-1496-2020, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 86101
- Address
- 3 Skyline Dr
- Code information
- a) AB28353, Exp 12/31/2021; b) AB40178, Exp 12/31/2021
- Postal code
- 10532-2174
- Report date
- Aug 19, 2020
- Product type
- Drugs
- Recall number
- D-1496-2020
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 7632 tubes
- Termination date
- Jun 20, 2023
- Reason for recall
- Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jul 20, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2020