Recalls / Class II
Class IID-0121-2021
Product
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.
- Brand name
- Busulfan
- Generic name
- Busulfan
- Active ingredient
- Busulfan
- Route
- Intravenous
- NDC
- 72485-210
- FDA application
- ANDA210931
- Affected lot / code info
- Lot #: 7S10008B, Exp. 12/31/2020
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
- 2,064 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-0121-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.