Recalls / Class II
Class IID-0569-2023
Product
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
- Brand name
- Fyremadel
- Generic name
- Ganirelix Acetate
- Active ingredient
- Ganirelix Acetate
- Route
- Subcutaneous
- NDC
- 55566-1010
- FDA application
- ANDA204246
- Affected lot / code info
- Lot #: HAD1190A, Exp. 02/2024
Why it was recalled
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Recalling firm
- Firm
- Sun Pharmaceutical Industries Ltd.
- Manufacturer
- Ferring Pharmaceuticals Inc.
- Notification channel
- N/A
- Type
- N/A
- Address
- Halol - Baroda Highway, N/A, Halol, N/A N/A, India
Distribution
- Quantity
- 24194 Prefilled Syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-04-19
- FDA classified
- 2023-05-10
- Posted by FDA
- 2023-05-03
- Terminated
- 2023-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0569-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.