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%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
Lot numbers, UPCs & expiration codes
Lot #: a) AB28535, Exp. Date: Dec. 2021 b) AB40178, Exp. Date: Dec. 2021
Where it was sold
Nationwide within the United States
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-1497-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 24, 2020
- FDA report date
- Aug 19, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-1497-2020, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 86129
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: a) AB28535, Exp. Date: Dec. 2021 b) AB40178, Exp. Date: Dec. 2021
- Postal code
- 93012-8601
- Report date
- Aug 19, 2020
- Product type
- Drugs
- Recall number
- D-1497-2020
- Classification
- Class III
- Recalling firm
- Golden State Medical Supply Inc.
- Termination date
- Dec 10, 2020
- 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%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2020