Class II · Moderate risk Ongoing
Azacitidine for Injection 100mg/Vial
Reason Lack of Sterility Assurance
Azacitidine for Injection 100 mg/vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
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.
- Recalling firm
- Shilpa Medicare Limited
- NDC code
- 72485-201-01
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0122-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Azacitidine recalls
See all
Class III · Low risk Terminated
Azacitidine for Injection
Reason Subpotent Drug
Class III · Low risk Terminated
Azacitidine for Injection 100mg/vial Lyophilized Powder
Reason Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class III · Low risk Terminated
Azacitidine
Reason Failed stability specifications
Class III · Low risk Terminated
Azacitidine
Reason Failed stability specifications
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