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AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSu...

FDA Recall #D-1101-2023 — Class II — August 9, 2023

Recall #D-1101-2023 Date: August 9, 2023 Classification: Class II Status: Completed

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.

Recalling Firm

Ecometics, Inc. — Norwalk, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

92,967 vials

Distribution

Nationwide in the USA

Code Information

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

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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