Recall: D-1086-2023

Class III - Minor Violations

Class IIIClassification

2023-07-27Initiated

OngoingStatus

ALEMBIC PHARMACEUTICALS, INC.Firm

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.