PlainRecalls
FDA Drug Moderate Class II Terminated

TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0533-2021

Product Description

TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

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

Frequently Asked Questions

What product was recalled?
TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT. Recalled by Cardinal Health Inc.. Units affected: 28 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-0533-2021.