D-0165-2021 Class II Terminated
FDA drug recall D-0165-2021 was initiated by CIPLA on Dec 14, 2020 and is designated Class II. Reason for recall: cGMP deviations: Vials may not be sealed correctly affecting sterility. The recall status is terminated (terminated Aug 16, 2022). Affected quantity: 2151 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 23, 2020
- Initiation Date
- Dec 14, 2020
- Termination Date
- Aug 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0165-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026