Drug product
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30
D-0261-2022
Product summary
- Firm
- ASP CARES
- Event
- Event 89076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 896 vials
- Official record key
drug-enforcement:D-0261-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 091721589 BUD: 03/16/2022
Distribution pattern: United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility