Why it was recalled
Superpotent Drug
Product description
Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
Lot numbers, UPCs & expiration codes
Lot #: 11557C1, Exp. Date: Feb 2022; 11552B1, Exp. Date Apr 2022; 12206A1, Exp. Date: Nov 2022
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-0282-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 8, 2021
- FDA report date
- Dec 22, 2021
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TOLMAR, Inc.
Original FDA data
Every field from FDA enforcement report D-0282-2022, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 88910
- Address
- 1201 Cornerstone Dr
- Code information
- Lot #: 11557C1, Exp. Date: Feb 2022; 11552B1, Exp. Date Apr 2022; 12206A1, Exp. Date: Nov 2022
- Postal code
- 80550-5547
- Report date
- Dec 22, 2021
- Product type
- Drugs
- Recall number
- D-0282-2022
- Classification
- Class II
- Recalling firm
- TOLMAR, Inc.
- Termination date
- Sep 7, 2022
- Reason for recall
- Superpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 8, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 14, 2021