Drug product

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

D-1473-2022

August 23, 2022

Class II

Product summary

Firm: Teva Pharmaceuticals USA Inc
Event: Event 90792
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: drug-enforcement:D-1473-2022

Official wording

Reason: 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.

Code information: Lot #: 3007830, 3007746, 3007829, Exp. Date 10/2024

Distribution pattern: Nationwide within the United States

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

foreign matter
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations