Why it was recalled
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 13635A1, Exp. 07/31/2024
Where it was sold
Nationwide in the US.
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-1178-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 12, 2023
- FDA report date
- Oct 4, 2023
- Quantity
- 2990 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tolmar, Inc.
Original FDA data
Every field from FDA enforcement report D-1178-2023, exactly as published.
Show all FDA fields
- City
- Fort Collins
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 93044
- Address
- 701 Centre Ave
- Code information
- Lot: 13635A1, Exp. 07/31/2024
- Postal code
- 80526-1843
- Report date
- Oct 4, 2023
- Product type
- Drugs
- Recall number
- D-1178-2023
- Classification
- Class III
- Recalling firm
- Tolmar, Inc.
- Product quantity
- 2990 cartons
- Termination date
- Oct 3, 2024
- Reason for recall
- Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Sep 12, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2023