Drug product
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
D-1465-2022
Product summary
- Event
- Event 90774
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1120 packages
- Official record key
drug-enforcement:D-1465-2022
Official wording
Reason: cGMP deviation: Product held outside of appropriate temperature storage conditions.
Code information: SKUs 998277 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Distribution pattern: Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Derived failure modes
-
Manufacturing or process control
cGMP deviation