Drug product
Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0204-2018
Product summary
- Event
- Event 78553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3612 vials
- Official record key
drug-enforcement:D-0204-2018
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: 06092017@2 BUD: 12/6/2017; 07212017@16 BUD: 1/17/2018; 07312017@26 BUD: 1/27/2018; 08182017@5 BUD: 2/14/2018; 09222017@2 BUD: 3/21/2018; 09292017@2 BUD: 3/28/2018; 10062017@2 BUD: 4/4/2018
Distribution pattern: Nationwide in the USA, Bermuda, and New Zealand
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing