FDAClass IIAugust 30, 2023

AstrinGyn recall: CGMP Deviations

AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref…

Why was AstrinGyn recalled?

CGMP Deviations: Products not manufactured under current good manufacturing practices.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 2E144A, 2E157A, exp: 11/2023; 2E270A, exp: 3/2024; 2E300A, exp: 4/2024

Product
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref…
Recalling firm
Ecometics, Inc.
Quantity
92,967 vials
Distribution
Nationwide in the USA
Recall date
August 30, 2023
Classification
Class II
Status
Completed
Agency
FDA (drug)
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