D-1473-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 7, 2022
- Initiation Date
- August 23, 2022
- Termination Date
- September 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 3007830, 3007746, 3007829, Exp. Date 10/2024