D-0165-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 23, 2020
- Initiation Date
- December 14, 2020
- Termination Date
- August 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2151 vials
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.
Distribution Pattern
USA Nationwide
Code Information
Lot #: 7S10182A, Ex 9/2021