PlainRecalls
FDA Drug Moderate Class II Terminated

Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0513-2021

Product Description

Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
189 tubes
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150. Recalled by Cardinal Health Inc.. Units affected: 189 tubes.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0513-2021.