Drug product
Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-9034-58
D-0579-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 bottles
- Official record key
drug-enforcement:D-0579-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 100016785
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations