D-1473-2022 Class II Terminated
FDA drug recall D-1473-2022 was initiated by Teva Pharmaceuticals USA Inc on Aug 23, 2022 and is designated Class II. 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. The recall status is terminated (terminated Sep 7, 2023).
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 7, 2022
- Initiation Date
- Aug 23, 2022
- Termination Date
- Sep 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1473-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026