PlainRecalls
FDA Drug Low Class III Ongoing

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

Reported: August 23, 2023 Initiated: July 27, 2023 #D-1086-2023

Product Description

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Units Affected
82,400 bottles
Distribution
Nationwide in the USA
Location
Bedminster, NJ

Frequently Asked Questions

What product was recalled?
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05. Recalled by ALEMBIC PHARMACEUTICALS, INC.. Units affected: 82,400 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on August 23, 2023. Severity: Low. Recall number: D-1086-2023.