Drug product
METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
D-0038-2023
Product summary
- Event
- Event 90982
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 514 vials
- Official record key
drug-enforcement:D-0038-2023
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Code information: Lot: 57997, BUD: 02/25/2023; 64941, BUD: 03/08/2023
Distribution pattern: AL, LA, MS, and TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility