Why it was recalled
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Product description
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
Lot numbers, UPCs & expiration codes
Lot# AC13786, exp. date DEC 2022
Where it was sold
Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
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-0375-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 15, 2021
- FDA report date
- Jan 19, 2022
- Quantity
- 96 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0375-2022, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89241
- Address
- 3 Skyline Dr
- Code information
- Lot# AC13786, exp. date DEC 2022
- Postal code
- 10532-2174
- Report date
- Jan 19, 2022
- Product type
- Drugs
- Recall number
- D-0375-2022
- Classification
- Class I
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 96 tubes
- Termination date
- Dec 4, 2023
- Reason for recall
- Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
- Distribution pattern
- Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
- Recall initiation date
- Dec 15, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2022