Drug product
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
D-1292-2022
Product summary
- Event
- Event 90545
- Status
- Terminated
- Classification
- Class I
- Quantity
- 253,200 pens (50,650/5 per packs)
- Official record key
drug-enforcement:D-1292-2022
Official wording
Reason: Labeling: Missing label: Label missing from some prefilled pens.
Code information: Lot #: BF21002895, Exp. Date Aug 2023
Distribution pattern: Product was distributed nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Missing label: Label missing