Why it was recalled
Lack of Assurance of Sterility: leaking bags
Product description
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
Lot numbers, UPCs & expiration codes
Lot#: 20231020FEN-1, Exp: 04/17/2024
Where it was sold
Nationwide within the U.S
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-0432-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 22, 2024
- FDA report date
- Apr 10, 2024
- Quantity
- 187 cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- IntegraDose Compounding Services LLC
Original FDA data
Every field from FDA enforcement report D-0432-2024, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 94275
- Address
- 719 Kasota Ave Se
- Code information
- Lot#: 20231020FEN-1, Exp: 04/17/2024
- Postal code
- 55414-2842
- Report date
- Apr 10, 2024
- Product type
- Drugs
- Recall number
- D-0432-2024
- Classification
- Class II
- Recalling firm
- IntegraDose Compounding Services LLC
- Product quantity
- 187 cassettes
- Reason for recall
- Lack of Assurance of Sterility: leaking bags
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
- Distribution pattern
- Nationwide within the U.S
- Recall initiation date
- Mar 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 3, 2024