Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azacitidine for Injection 100 mg/vial Recalled by Shilpa Medicare Limited Due to CGMP Deviations
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Shilpa Medicare Limited directly.
Affected Products
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.
Quantity: 35,931 vials
Why Was This Recalled?
CGMP Deviations
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Shilpa Medicare Limited
Shilpa Medicare Limited has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report