Drug product
Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
D-0174-2024
Product summary
- Event
- Event 89450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
drug-enforcement:D-0174-2024
Official wording
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Code information: Batch 1293US561C
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations