Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Busulfan Injection 60 mg/10 mL (6 mg/mL) 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
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.
Quantity: 2,064 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