Why it was recalled
Lack of Assurance of Sterility
Product description
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Lot numbers, UPCs & expiration codes
Lot # C274-000040409, Exp 03/22/2025
Where it was sold
Distributed in PA
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-0225-2025
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jan 31, 2025
- FDA report date
- Feb 26, 2025
- Quantity
- 1330 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron Compounding Services
Original FDA data
Every field from FDA enforcement report D-0225-2025, exactly as published.
Show all FDA fields
- City
- Wichita
- State
- KS
- Status
- Completed
- Country
- United States
- Event ID
- 96232
- Address
- 8710 E 34th St N
- Code information
- Lot # C274-000040409, Exp 03/22/2025
- Postal code
- 67226-2636
- Report date
- Feb 26, 2025
- Product type
- Drugs
- Recall number
- D-0225-2025
- Classification
- Class II
- Recalling firm
- Fagron Compounding Services
- Product quantity
- 1330 bags
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
- Distribution pattern
- Distributed in PA
- Recall initiation date
- Jan 31, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 19, 2025