Why it was recalled
Lack of Assurance of Sterility
Product description
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
Lot numbers, UPCs & expiration codes
ProRx061424, BUD 12/13/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0653-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 22, 2024
- FDA report date
- Sep 11, 2024
- Quantity
- 1,960 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ProRx LLC
Original FDA data
Every field from FDA enforcement report D-0653-2024, exactly as published.
Show all FDA fields
- City
- Exton
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95190
- Address
- 619 Jeffers Cir
- Code information
- ProRx061424, BUD 12/13/2024
- Postal code
- 19341-2540
- Report date
- Sep 11, 2024
- Product type
- Drugs
- Recall number
- D-0653-2024
- Classification
- Class II
- Recalling firm
- ProRx LLC
- Product quantity
- 1,960 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Sep 5, 2024