PlainRecalls
FDA Drug Moderate Class II Terminated

TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0446-2021

Product Description

TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

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

Frequently Asked Questions

What product was recalled?
TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS. Recalled by Cardinal Health Inc.. Units affected: 47 droptainers.
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-0446-2021.