Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01

Recall Number: D-1473-2022

Firm: Teva Pharmaceuticals USA Inc

Classification: Class II

Status: Terminated

Report Date: 20220907

Initiation Date: 20220823

Termination Date: 20230907

Reason for Recall

CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

Product Description

Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01