Why it was recalled
Lack of sterility assurance.
Product description
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
Lot numbers, UPCs & expiration codes
Lots: 745708 BUD: 6/21/2022; 753364 BUD: 7/27/2022; 752508 BUD: 7/24/2022; 750313 BUD: 7/16/2022; 753020 BUD: 7/26/2022; 747712 BUD: 7/4/2022; 747974 BUD: 7/5/2022; 754802 BUD: 8/3/2022; 751158 BUD: 7/19/2022; 756837 BUD: 8/16/2022; 748939 BUD: 7/10/2022; 750842 BUD: 7/18/2022; 755742 BUD: 8/8/2022; 758691 BUD: 8/28/2022; 758432 BUD: 8/27/2022; 758975 BUD: 8/29/2022; 756643 BUD: 8/15/2022
Where it was sold
Nationwide in the USA including Puerto Rico.
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-0728-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 23, 2022
- FDA report date
- Apr 6, 2022
- Quantity
- 6017 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Drug Depot, Inc., dba APS Pharmacy
Original FDA data
Every field from FDA enforcement report D-0728-2022, exactly as published.
Show all FDA fields
- City
- Palm Harbor
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 89808
- Address
- 34911 Us Highway 19 N Ste 600
- Code information
- Lots: 745708 BUD: 6/21/2022; 753364 BUD: 7/27/2022; 752508 BUD: 7/24/2022; 750313 BUD: 7/16/2022; 753020 BUD: 7/26/2022; 747712 BUD: 7/4/2022; 747974 BUD: 7/5/2022; 754802 BUD: 8/3/2022; 751158 BUD: 7/19/2022; 756837 BUD: 8/16/2022; 748939 BUD: 7/10/2022; 750842 BUD: 7/18/2022; 755742 BUD: 8/8/2022; 758691 BUD: 8/28/2022; 758432 BUD: 8/27/2022; 758975 BUD: 8/29/2022; 756643 BUD: 8/15/2022
- Postal code
- 34684-1921
- Report date
- Apr 6, 2022
- Product type
- Drugs
- Recall number
- D-0728-2022
- Classification
- Class II
- Recalling firm
- Drug Depot, Inc., dba APS Pharmacy
- Product quantity
- 6017 vials
- Termination date
- Oct 5, 2023
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
- Distribution pattern
- Nationwide in the USA including Puerto Rico.
- Recall initiation date
- Mar 23, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2022