Why it was recalled
Lack of Assurance of Sterility: Firm did not perform process validation.
Product description
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1
Lot numbers, UPCs & expiration codes
Lot #s: 20240109-837CB8, Exp. 07-Jul-2024; 20231219-08D09D, Exp. 16-Jun-2024; 20231121-20F8BB, Exp. 19-May-2024; 20231115-2FF64D, Exp. 13-May-2024; 20231101-09C52B, Exp. 29-Apr-2024; 20231010-3D0B35, Exp. 07-Apr-2024; 20230912-847E0C, Exp. 10-Mar-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-0435-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 29, 2024
- FDA report date
- Apr 10, 2024
- Quantity
- 11,798 syringes
- 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-0435-2024, 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 #s: 20240109-837CB8, Exp. 07-Jul-2024; 20231219-08D09D, Exp. 16-Jun-2024; 20231121-20F8BB, Exp. 19-May-2024; 20231115-2FF64D, Exp. 13-May-2024; 20231101-09C52B, Exp. 29-Apr-2024; 20231010-3D0B35, Exp. 07-Apr-2024; 20230912-847E0C, Exp. 10-Mar-2024.
- Postal code
- 63026-2394
- Report date
- Apr 10, 2024
- Product type
- Drugs
- Recall number
- D-0435-2024
- Classification
- Class II
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Product quantity
- 11,798 syringes
- Reason for recall
- Lack of Assurance of Sterility: Firm did not perform process validation.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1
- Distribution pattern
- MO
- Recall initiation date
- Feb 29, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2024