Fort Collins, CO, United States
Tolmar, Inc. recalls
3 recalls recorded since 2018, most recently on 12 September 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 12 September 2023
- Terminated
- 3 October 2024
- Reason
- Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
- Distribution
- Nationwide in the US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1178-2023
- Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeut
Terminated Class II Drugs
- Recall started
- 11 July 2022
- Terminated
- 22 June 2023
- Reason
- Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
- Distribution
- distributed to 1 consignee in KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1300-2022
- 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, In
Terminated Class II Drugs
- Recall started
- 8 November 2021
- Terminated
- 7 September 2022
- Reason
- Superpotent Drug
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0282-2022
- Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.