Recall D-0321-2024
Description: Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Recall D-0321-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0321-2024 |
| Event ID | 93867 |
| Brand | NORTREL |
| Generic Name | NORETHINDRONE AND ETHINYL ESTRADIOL |
| Manufacturer | NORETHINDRONE AND ETHINYL ESTRADIOL |
| Original Package? | 1 |
| Distribution | nationwide |
| Quantity | 12,916 cartons |
| Recall Reason | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. |
| Drug Classification | Class III |
| Drug Code Info | 20240221 |
| Product NDC | 0555-9008 0555-9009 0555-9010 |
| Product NUI | N0000175825 N0000000100 M0447349 |
| Pharma Class (EPC) | Estrogen [EPC] |
| Pharma Class (CS) | Progesterone Congeners [CS] |
| Recall Initiation Date | 20240125 |
| Report Date | 20240221 |
| Classification Date | 20240212 |
| Address | 400 Interpace Pkwy Bldg A Parsippany, NJ 07054-1120 United States |
| Recalling Firm | Teva Pharmaceuticals USA, Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 423D2T571U T18F433X4S |
| Drug Application Number | ANDA072695 |
| Structured Product Labeling (SPL ID) | 76509f88-35fd-458f-be86-65c5c1e828bc |
| Structured Product Labeling (SPL Set ID) | 140c50d6-c931-423a-9aa0-526eae7ab93c |
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