Status
Completed
Drug Enforcement D-1101-2023
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Classification
Class II
Report Date
August 30, 2023
Termination Date
—
Product Information
- Product description
- AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
- Product quantity
- 92,967 vials
- Reason for recall
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Ecometics, Inc.
- Address
-
19 Concord St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1101-2023
- Event ID
- 92857
- Recall initiation date
- August 9, 2023
- Center classification date
- August 24, 2023
- Code info
- Lot #: 2E144A, 2E157A, exp: 11/2023; 2E270A, exp: 3/2024; 2E300A, exp: 4/2024
- More code info
- —