Home / Recalls / ALEMBIC PHARMACEUTICALS, INC. / D-1086-2023

D-1086-2023 Class III Ongoing

Recalled by ALEMBIC PHARMACEUTICALS, INC. — Bedminster, NJ

Recall Details

Product Type: Drugs
Report Date: August 23, 2023
Initiation Date: July 27, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 82,400 bottles

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024