PlainRecalls
FDA Drug Moderate Class II Terminated

TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01

Reported: June 15, 2022 Initiated: April 13, 2022 #D-0995-2022

Product Description

TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
3 tubes
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 3 tubes.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-0995-2022.