NEOMYCIN SULFATE Recall D-1473-2022
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
NEOMYCIN SULFATE Recall D-1473-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1473-2022 |
| Event ID | 90792 |
| Brand | NEOMYCIN SULFATE |
| Generic Name | NEOMYCIN SULFATE |
| Manufacturer | NEOMYCIN SULFATE |
| Original Package? | 1 |
| Active Substance | NEOMYCIN SULFATE |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20220907 |
| Product NDC | 0093-1177 |
| Drug UPC | 0300931177018 |
| Recall Initiation Date | 20220823 |
| Report Date | 20220907 |
| Classification Date | 20220830 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 057Y626693 |
| Drug Application Number | ANDA060304 |
| Structured Product Labeling (SPL ID) | 941cf1b7-9d5b-4c06-9f4e-24c2f9e7c457 |
| Structured Product Labeling (SPL Set ID) | 777dbfab-f83e-4738-ae1e-78619a9f82a7 |
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