Busulfan Injection, Solution
FDA Recall NDC 72485-210
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Busulfan (NDC 72485-210). A significant event, classified as Class II, was initiated on Dec 08, 2020 by Armas Pharmaceuticals Inc.. The reported reason for this action was: "CGMP Deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations
Dec 08, 2020
Dec 16, 2020
2,064 vials
Recall Profile & Regulatory Data
Event ID
86749
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Shilpa Medicare Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Mar 11, 2022
Product Description
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.
Batch or Lot Expiration Information
Lot# : 7S10008B, Exp. 12/31/2020
Affected Packages Involved in this Recall
72485-210-01Product
72485-210-08Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
