D-0121-2021 Class II Terminated
FDA drug recall D-0121-2021 was initiated by Shilpa Medicare Limited on December 8, 2020 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated March 11, 2022). Affected quantity: 2,064 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- December 16, 2020
- Initiation Date
- December 8, 2020
- Termination Date
- March 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,064 vials
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.
Reason for Recall
CGMP Deviations
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: 7S10008B, Exp. 12/31/2020