Drug product
Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.
D-1394-2019
Product summary
- Event
- Event 82854
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,386 cartons
- Official record key
drug-enforcement:D-1394-2019
Official wording
Reason: GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Code information: Lot #: 175289A, 175286B, 175290B, Exp. 08/31/2019; 179906A, Exp. 03/31/2020; 183252A, Exp. 09/30/2020; 184611A, Exp. 11/30/2020
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Manufacturing or process control
GMP Deviations