Why it was recalled
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Product description
Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Lot numbers, UPCs & expiration codes
Lot #: a) 12070A, Exp 5/2023; 11801A, Exp 9/2022; b) 12386A, Exp 8/2023; 11800A, Exp 9/2022; c) 11940A, Exp 12/2022
Where it was sold
distributed to 1 consignee in KY.
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-1300-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2022
- FDA report date
- Aug 10, 2022
- Quantity
- 1271 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tolmar, Inc.
Original FDA data
Every field from FDA enforcement report D-1300-2022, exactly as published.
Show all FDA fields
- City
- Fort Collins
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 90580
- Address
- 701 Centre Ave
- Code information
- Lot #: a) 12070A, Exp 5/2023; 11801A, Exp 9/2022; b) 12386A, Exp 8/2023; 11800A, Exp 9/2022; c) 11940A, Exp 12/2022
- Postal code
- 80526-1843
- Report date
- Aug 10, 2022
- Product type
- Drugs
- Recall number
- D-1300-2022
- Classification
- Class II
- Recalling firm
- Tolmar, Inc.
- Product quantity
- 1271 tubes
- Termination date
- Jun 22, 2023
- Reason for recall
- Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Distribution pattern
- distributed to 1 consignee in KY.
- Recall initiation date
- Jul 11, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2022