Drug product
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
D-0462-2022
Product summary
- Event
- Event 89357
- Status
- Terminated
- Classification
- Class I
- Quantity
- 73,175 prefilled pens
- Official record key
drug-enforcement:D-0462-2022
Official wording
Reason: Labeling: Missing Label: label missing from some Semglee prefilled pens.
Code information: Batch # BF20003118, Exp. August 2022
Distribution pattern: Nationwide in the USA and Thailand.
Derived failure modes
-
Labeling or packaging
Labeling: Missing Label: label missing