INSULIN GLARGINE Recall D-0845-2022
Description: Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80
INSULIN GLARGINE Recall D-0845-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0845-2022 |
| Event ID | 89970 |
| Brand | INSULIN GLARGINE |
| Generic Name | INSULIN GLARGINE-YFGN |
| Manufacturer | INSULIN GLARGINE-YFGN |
| Original Package? | 1 |
| Active Substance | INSULIN GLARGINE |
| Drug Route | SUBCUTANEOUS |
| Distribution | USA nationwide. |
| Quantity | 89,665 vials |
| Recall Reason | Labeling: Missing label on the vial |
| Drug Classification | Class I |
| Drug Code Info | 20220504 |
| Product NDC | 49502-393 49502-394 |
| Product NUI | M0011417 N0000175453 |
| Pharma Class (EPC) | Insulin Analog [EPC] |
| Pharma Class (CS) | Insulin [CS] |
| Recall Initiation Date | 20220412 |
| Report Date | 20220504 |
| Classification Date | 20220504 |
| Address | 3711 Collins Ferry Rd Morgantown, WV 26505-2362 United States |
| Recalling Firm | Mylan Pharmaceuticals Inc |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 2ZM8CX04RZ |
| Drug Application Number | BLA761201 |
| Structured Product Labeling (SPL ID) | a14de887-e390-4d3f-8863-48ca77969e2e |
| Structured Product Labeling (SPL Set ID) | f8cf3733-952d-4cf1-99ff-5ec7b7247f75 |
| Similar To |