Recalls / Class II
Class IID-0123-2021
Product
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
- Affected lot / code info
- Lot #: 7S10227A, Exp. 10/31/2021
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Shilpa Medicare Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- S-20 To S-26, Pharm. Formulation Sez, Tsiic, Green Industrial Park, Polepally, Jadcherla, N/A N/A, India
Distribution
- Quantity
- 6,560 vials
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-12-08
- FDA classified
- 2020-12-09
- Posted by FDA
- 2020-12-16
- Terminated
- 2022-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0123-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.