Drug product
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328
D-0430-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 244 bottles
- Official record key
drug-enforcement:D-0430-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 78520
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations