Reported Aug 30, 2023 · Completed
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT…
Ecometics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ecometics, Inc. · 19 Concord St · Norwalk, CT · 06854-3706
Is this the product you have?
AstrinGyn (Ferric Subsulfate) Aqueous259 mg/g8 gm Single Use VialsManufactured for CooperSurgicalTrumbullCT 06611NDC 59365-6065-0Ref 6065
- Lot codes and dates
Lot #: 2E144A2E157A
- exp
11/20232E270A
- exp
3/20242E300A
- exp4/2024
- Amount recalled
- 92,967 vials
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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