Drug product
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
D-0997-2020
Product summary
- Event
- Event 85127
- Status
- Terminated
- Classification
- Class II
- Quantity
- 260,000 tubes
- Official record key
drug-enforcement:D-0997-2020
Official wording
Reason: cGMP Deviation
Code information: Lot #: 20180621 Exp. 2020-06-21, 20180827 Exp. 2020-08-27, 20190115 Exp. 2021-01-15
Distribution pattern: Florida only
Derived failure modes
-
Manufacturing or process control
cGMP Deviation