Drug product
Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0205-2018
Product summary
- Event
- Event 78553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5786 vials
- Official record key
drug-enforcement:D-0205-2018
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information: Lots; 05232017@13 BUD: 11/19/2017; 05262017@2 BUD: 11/22/2017; 06022017@1 BUD: 11/29/2017; 06092017@1 BUD: 12/6/2017; 06162017@10 BUD: 12/13/2017; 08142017@10 BUD: 2/10/2018; 08252017@1 BUD: 2/21/2018; 09222017@1 BUD: 3/21/2018; 09292017@1 BUD: 3/28/2018; 10062017@1 BUD: 4/4/2018; 10132017@2 BUD: 4/11/2018
Distribution pattern: Nationwide in the USA, Bermuda, and New Zealand
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing