Drug product
LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01
D-0557-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 bottles
- Official record key
drug-enforcement:D-0557-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 20D27
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations