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FDADecember 14, 2020drug

Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

cGMP deviations: Vials may not be sealed correctly affecting sterility.

What to do

FDA enforcement status: Terminated

Brands named

cipla

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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