Drug product
Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50
D-0262-2022
Product summary
- Firm
- ASP CARES
- Event
- Event 89076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3077 vials
- Official record key
drug-enforcement:D-0262-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 092321690 BUD: 03/22/2022; 093021690 BUD: 03/29/2022
Distribution pattern: United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility