FDA recall D-0165-2021

Product

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.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-14

Report date

2020-12-23

Termination date

2022-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2021