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Recall Observatory FDA recall evidence

Drug product

Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.

D-0069-2019

August 03, 2018

Class III

Product summary

Firm
Product Quest Manufacturing LLC
Event
Event 80750
Status
Terminated
Classification
Class III
Quantity
6,516 tubes
Official record key
drug-enforcement:D-0069-2019

Official wording

Reason: Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

Code information: Lot: 163241K, Exp. October 2018

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent