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Recall Observatory FDA recall evidence

Drug product

Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.

D-0590-2018

February 23, 2018

Class II

Product summary

Firm
Bayer HealthCare Pharmaceuticals, Inc.
Event
Event 79252
Status
Terminated
Classification
Class II
Quantity
528 units
Official record key
drug-enforcement:D-0590-2018

Official wording

Reason: Labeling: Label mix-up

Code information: Lot#: 7N04CS, 7N05CS, Exp. 11/2019

Distribution pattern: Arkansas only

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label mix-up