Status
Terminated
Drug Enforcement D-0569-2023
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Classification
Class II
Report Date
May 3, 2023
Termination Date
December 13, 2023
Product Information
- 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
- Product quantity
- 24194 Prefilled Syringes
- Reason for recall
- Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
- Recall initiation reason
- —
- Initial firm notification
- N/A
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Sun Pharmaceutical Industries Ltd.
- Address
-
Halol - Baroda Highway, N/A
India - Voluntary / Mandated
- N/A
- Status date
- —
Codes & Dates
- Recall number
- D-0569-2023
- Event ID
- 92140
- Recall initiation date
- April 19, 2023
- Center classification date
- May 10, 2023
- Code info
- Lot #: HAD1190A, Exp. 02/2024
- More code info
- —