FDA Drug recall D-0121-2021
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic A…
- FDA Drug
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic A… by Shilpa Medicare, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0121-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-08 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shilpa Medicare |
| Distribution | US |
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.
Reason
CGMP Deviations
Identifiers
| code_info | Lot #: 7S10008B, Exp. 12/31/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Shilpa Medicare
- PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmeda…
FDA Drug · Class II · 2026-08-26 · Shilpa Medicare - PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedab…
FDA Drug · Class II · 2026-08-26 · Shilpa Medicare - Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactu…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare - Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmace…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare - Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmace…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0121-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.