Recalls / Class II
Class IID-1101-2023
Product
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
- Affected lot / code info
- Lot #: 2E144A, 2E157A, exp: 11/2023; 2E270A, exp: 3/2024; 2E300A, exp: 4/2024
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recalling firm
- Firm
- Ecometics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 19 Concord St, N/A, Norwalk, Connecticut 06854-3706
Distribution
- Quantity
- 92,967 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-09
- FDA classified
- 2023-08-24
- Posted by FDA
- 2023-08-30
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1101-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.