Why it was recalled
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Product description
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
Lot numbers, UPCs & expiration codes
Lot #: HAD1190A, Exp. 02/2024
Where it was sold
Nationwide in the USA
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-0569-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 19, 2023
- FDA report date
- May 3, 2023
- Quantity
- 24194 Prefilled Syringes
- Recall type
- N/A
- Recalling firm
- Sun Pharmaceutical Industries Ltd.
Original FDA data
Every field from FDA enforcement report D-0569-2023, exactly as published.
Show all FDA fields
- City
- Halol
- Status
- Terminated
- Country
- India
- Event ID
- 92140
- Address
- Halol - Baroda Highway
- Code information
- Lot #: HAD1190A, Exp. 02/2024
- Report date
- May 3, 2023
- Product type
- Drugs
- Recall number
- D-0569-2023
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries Ltd.
- Product quantity
- 24194 Prefilled Syringes
- Termination date
- Dec 13, 2023
- Reason for recall
- Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
- Product description
- Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 19, 2023
- Center classification date
- May 10, 2023