AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
Reported: August 30, 2023 Initiated: August 9, 2023 #D-1101-2023
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.
Reason for Recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Details
- Recalling Firm
- Ecometics, Inc.
- Units Affected
- 92,967 vials
- Distribution
- Nationwide in the USA
- Location
- Norwalk, CT
Frequently Asked Questions
What product was recalled? ▼
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.. Recalled by Ecometics, Inc.. Units affected: 92,967 vials.
Why was this product recalled? ▼
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 30, 2023. Severity: Moderate. Recall number: D-1101-2023.
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