Drug product
Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0161-2018
Product summary
- Event
- Event 78553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,700 capsules
- Official record key
drug-enforcement:D-0161-2018
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: 03092017@21 BUD: 3/9/2018; 03292017@33 BUD: 3/24/2018; 05092017@38 BUD: 5/4/2018; 05162017@31 BUD: 5/11/2018; 05182017@25 BUD: 5/13/2018; 07032017@40 BUD: 6/28/2018; 07142017@34 BUD: 7/9/2018; 07192017@32 BUD: 7/14/2018; 08282017@25 BUD: 8/23/2018; 09142017@8BUD: 9/9/2018; 09212017@23 BUD: 9/16/2018; 09272017@36 BUD: 9/ 22/2018; 10162017@39 BUD: 10/11/2018; 11032017@28 BUD: 10/29/2018
Distribution pattern: Nationwide in the USA, Bermuda, and New Zealand
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing