Why it was recalled
Lack of Assurance of Sterility: Firm did not perform process validation.
Product description
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
Lot numbers, UPCs & expiration codes
Lot: 20231031-0C91D9, Exo 29-Feb-2024.
Where it was sold
MO
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-0436-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 29, 2024
- FDA report date
- Apr 10, 2024
- Quantity
- 140 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
Original FDA data
Every field from FDA enforcement report D-0436-2024, exactly as published.
Show all FDA fields
- City
- Fenton
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 94198
- Address
- 1015 Bowles Ave
- Code information
- Lot: 20231031-0C91D9, Exo 29-Feb-2024.
- Postal code
- 63026-2394
- Report date
- Apr 10, 2024
- Product type
- Drugs
- Recall number
- D-0436-2024
- Classification
- Class II
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Product quantity
- 140 vials
- Reason for recall
- Lack of Assurance of Sterility: Firm did not perform process validation.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
- Distribution pattern
- MO
- Recall initiation date
- Feb 29, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2024