FDA DrugsClass III
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx...
Published: May 27, 2026Recall ID: D-0539-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications
Product Description & Identification
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Additional Source Details
| Field | Value |
|---|---|
| City | Schaumburg |
| State | IL |
| Openfda › Nui › 1 | N0000000236 |
| Openfda › Nui › 2 | N0000175558 |
| Openfda › Unii | G1LN9045DK |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui | 253113 |
| Openfda › Spl id | 673100ef-2b51-4ba2-af5c-fe7c52220636 |
| Openfda › Brand name | BUSULFAN |
| Openfda › Spl set id | 086a715e-4958-4bb5-9ebd-86171e6b6203 |
| Openfda › Package ndc | 25021-241-10 |
| Openfda › Product ndc | 25021-241 |
| Openfda › Generic name | BUSULFAN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | BUSULFAN |
| Openfda › Pharm class epc | Alkylating Drug [EPC] |
| Openfda › Pharm class moa | Alkylating Activity [MoA] |
| Openfda › Manufacturer name | Sagent Pharmaceuticals |
| Openfda › Application number | ANDA207050 |
| Openfda › Is original packager | true |
| Event id | 98883 |
| Address 1 | 1515 E Woodfield Rd Ste 1100 |
| Code info | Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027. |
| Postal code | 60173-6067 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260504 |
| Initial firm notification | Letter |
| Center classification date | 20260518 |
Overview
- Recalling FirmSagent Pharmaceuticals
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide within the United States