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

D-1086-2023 Class III Ongoing

Recalled by ALEMBIC PHARMACEUTICALS, INC. — Bedminster, NJ

FDA drug recall D-1086-2023 was initiated by ALEMBIC PHARMACEUTICALS, INC. on Jul 27, 2023 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is ongoing. Affected quantity: 82,400 bottles.

Recall Details

Product Type: Drugs
Report Date: Aug 23, 2023
Initiation Date: Jul 27, 2023
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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1086-2023
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.