Drug 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
D-0165-2021
Product summary
- Firm
- CIPLA
- Event
- Event 86969
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2151 vials
- Official record key
drug-enforcement:D-0165-2021
Official wording
Reason: cGMP deviations: Vials may not be sealed correctly affecting sterility.
Code information: Lot #: 7S10182A, Ex 9/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations