Recalls / Class III
Class IIID-1178-2023
Product
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 Therapeutics Inc., Fort Collins, CO 80526.
- Brand name
- Eligard
- Generic name
- Leuprolide Acetate
- Route
- Subcutaneous
- NDCs
- 62935-223, 62935-753, 62935-303, 62935-453
- FDA application
- NDA021379
- Affected lot / code info
- Lot: 13635A1, Exp. 07/31/2024
Why it was recalled
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Recalling firm
- Firm
- Tolmar, Inc.
- Manufacturer
- TOLMAR Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 701 Centre Ave, N/A, Fort Collins, Colorado 80526-1843
Distribution
- Quantity
- 2990 cartons
- Distribution pattern
- Nationwide in the US.
Timeline
- Recall initiated
- 2023-09-12
- FDA classified
- 2023-09-27
- Posted by FDA
- 2023-10-04
- Terminated
- 2024-10-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1178-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.