Status
Ongoing
Drug Enforcement D-0393-2025
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.
Classification
Class II
Report Date
May 7, 2025
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 48 Cartons
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- NC, SC, VA
Location & Firm
- Recalling firm
- Cardinal Health Inc.
- Address
-
7000 Cardinal Pl, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0393-2025
- Event ID
- 96637
- Recall initiation date
- April 9, 2025
- Center classification date
- April 28, 2025
- Code info
- Lot PZFDE06, Exp 08/31/2025
- More code info
- —