Drug product
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
D-0845-2022
Product summary
- Event
- Event 89970
- Status
- Terminated
- Classification
- Class I
- Quantity
- 89,665 vials
- Official record key
drug-enforcement:D-0845-2022
Official wording
Reason: Labeling: Missing label on the vial
Code information: Lot #: BF21002800, Exp 8/2023
Distribution pattern: USA nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Missing