Recalls / Class II
Class IID-0122-2021
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, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
- Brand name
- Azacitidine
- Generic name
- Azacitidine
- Active ingredient
- Azacitidine
- Route
- Intravenous, Subcutaneous
- NDC
- 72485-201
- FDA application
- ANDA207518
- Affected lot / code info
- Lot #s: 7S10115A, Exp. 07/31/2021; 7S10143A, 7S10182B, Exp. 09/30/2021; 7S10255A, 7S10256A, 7S10263A, Exp. 11/30/2021; 7T10028A, 12/31/2021; 7T10040A, Exp. 01/31/2022.
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Shilpa Medicare Limited
- Manufacturer
- Armas Pharmaceuticals Inc.
- 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
- 35,931 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-0122-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.