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Recall Observatory FDA recall evidence

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

August 10, 2022

Class II

Product summary

Firm
Family Dollar Stores, Llc.
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

    reason.manufacturing_process_control · v1.0.0

    cGMP deviation