Why it was recalled
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Product description
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
Lot numbers, UPCs & expiration codes
Lot #: AC33883, Exp. Date June 2023
Where it was sold
Product was distributed to one retail consignee in NY.
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-0727-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 25, 2022
- FDA report date
- Apr 6, 2022
- Quantity
- 768 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0727-2022, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89678
- Address
- 3 Skyline Dr
- Code information
- Lot #: AC33883, Exp. Date June 2023
- Postal code
- 10532-2174
- Report date
- Apr 6, 2022
- Product type
- Drugs
- Recall number
- D-0727-2022
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 768 tubes
- Termination date
- Sep 9, 2024
- Reason for recall
- Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
- Distribution pattern
- Product was distributed to one retail consignee in NY.
- Recall initiation date
- Feb 25, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2022