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Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Si...

FDA Recall #D-0123-2021 — Class II — December 8, 2020

Recall #D-0123-2021 Date: December 8, 2020 Classification: Class II Status: Terminated

Product Description

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.

Reason for Recall

CGMP Deviations

Recalling Firm

Shilpa Medicare Limited — Polepally, Jadcherla, N/A

Classification

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

Product Type

Drugs

Product Quantity

6,560 vials

Distribution

Nationwide in the U.S.

Code Information

Lot #: 7S10227A, Exp. 10/31/2021

Status

Terminated

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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