Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial ...
FDA Recall #D-0165-2021 — Class II — December 14, 2020
Product Description
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
Reason for Recall
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Recalling Firm
CIPLA — Warren, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2151 vials
Distribution
USA Nationwide
Code Information
Lot #: 7S10182A, Ex 9/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated