CIPLA product recalled over manufacturing violations

Recall date

December 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CIPLA recalls Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa…

Recall number

D-0165-2021

FDA classification

Class II

Brand / firm

CIPLA

Sold / distributed

USA Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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