Class II
Terminated
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
This recall has been terminated (originally issued December 23, 2020).
- Company
- Cipla
- Recall Initiated
- December 14, 2020
- Posted
- December 23, 2020
- Recall Number
- D-0165-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2151 vials
- Firm Location
- Warren, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Distribution
USA Nationwide
Lot / Code Info
Lot #: 7S10182A, Ex 9/2021
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