Drug product
Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0177-2018
Product summary
- Event
- Event 78553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,862 vials
- Official record key
drug-enforcement:D-0177-2018
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: 06222017@10 BUD: 12/19/2017; 09272017@14 BUD: 3/26/2018; 05312017@5 BUD: 11/27/2017; 07192017@8 BUD: 1/15/2018
Distribution pattern: Nationwide in the USA, Bermuda, and New Zealand
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing