Drug product
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
D-0393-2025
Product summary
- Event
- Event 96637
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48 Cartons
- Official record key
drug-enforcement:D-0393-2025
Official wording
Reason: Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Code information: Lot PZFDE06, Exp 08/31/2025
Distribution pattern: NC, SC, VA
Derived failure modes
-
Unknown
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.