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Recall Observatory FDA recall evidence

Drug product

Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010

D-0542-2021

March 15, 2021

Class II

Product summary

Firm
Cardinal Health Inc.
Event
Event 87512
Status
Terminated
Classification
Class II
Quantity
5 tubes
Official record key
drug-enforcement:D-0542-2021

Official wording

Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Code information: All Lots distributed 02/23/2021 through 03/10/2021.

Distribution pattern: FL, GA, SC

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations