INSULIN GLARGINE Recall D-1292-2022
Description: Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV
INSULIN GLARGINE Recall D-1292-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1292-2022 |
| Event ID | 90545 |
| Brand | INSULIN GLARGINE |
| Generic Name | INSULIN GLARGINE-YFGN |
| Manufacturer | INSULIN GLARGINE-YFGN |
| Original Package? | 1 |
| Active Substance | INSULIN GLARGINE |
| Drug Route | SUBCUTANEOUS |
| Distribution | Product was distributed nationwide within the United States |
| Quantity | 253,200 pens (50,650/5 per packs) |
| Recall Reason | Labeling: Missing label: Label missing from some prefilled pens. |
| Drug Classification | Class I |
| Drug Code Info | 20220803 |
| Product NDC | 49502-393 49502-394 |
| Product NUI | M0011417 N0000175453 |
| Pharma Class (EPC) | Insulin Analog [EPC] |
| Pharma Class (CS) | Insulin [CS] |
| Recall Initiation Date | 20220705 |
| Report Date | 20220803 |
| Classification Date | 20220726 |
| Address | 5005 Greenbag Rd Morgantown, WV 26501-7124 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 |
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