Drug product
Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0178-2018
Product summary
- Event
- Event 78553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,274 vials
- Official record key
drug-enforcement:D-0178-2018
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: 06082017@33 BUD: 12/5/2017; 06152017@4 BUD: 12/12/2017; 07272017@4 BUD: 1/23/2018; 10042017@22 BUD: 4/2/2018; 09282017@3 BUD: 3/27/2018
Distribution pattern: Nationwide in the USA, Bermuda, and New Zealand
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing