Drug product
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00
D-0925-2018
Product summary
- Event
- Event 80387
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3214 prefilled pens
- Official record key
drug-enforcement:D-0925-2018
Official wording
Reason: Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Code information: Lot #: 7F021B, Exp 6/30/20
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.