Class III Recall

ALEMBIC PHARMACEUTICALS, INC.

Product
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Reason
Failed Impurities/Degradation Specifications
Classification
Class III
Status
Ongoing
Lot
Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.