D-0569-2023 Class II Terminated
FDA drug recall D-0569-2023 was initiated by Sun Pharmaceutical Industries Ltd. on April 19, 2023 and is designated Class II. Reason for recall: Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. The recall status is terminated (terminated December 13, 2023). Affected quantity: 24194 Prefilled Syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 3, 2023
- Initiation Date
- April 19, 2023
- Termination Date
- December 13, 2023
- Voluntary/Mandated
- N/A
- Product Quantity
- 24194 Prefilled Syringes
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
Reason for Recall
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: HAD1190A, Exp. 02/2024