Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #: 7S10182A, Ex 9/2021
Why it was recalled
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Recalling firm
- Firm
- CIPLA
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 2151 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-12-14
- FDA classified
- 2020-12-16
- Posted by FDA
- 2020-12-23
- Terminated
- 2022-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0165-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.