PlainRecalls
FDA Drug Moderate Class II Ongoing

Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

Reported: June 7, 2023 Initiated: April 26, 2023 #D-0851-2023

Product Description

Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

Reason for Recall

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Details

Recalling Firm
Akorn, Inc.
Units Affected
N/A
Distribution
Nationwide in the USA and Puerto Rico
Location
Gurnee, IL

Frequently Asked Questions

What product was recalled?
Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs. Recalled by Akorn, Inc.. Units affected: N/A.
Why was this product recalled?
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0851-2023.