Why it was recalled
Lack of Assurance of Sterility
Product description
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1
Lot numbers, UPCs & expiration codes
Lot 210806-015, exp 11/4/2021
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-0007-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 22, 2021
- FDA report date
- Oct 20, 2021
- Quantity
- 385 bags
- 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-0007-2022, exactly as published.
Show all FDA fields
- City
- Fenton
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 88758
- Address
- 1015 Bowles Ave
- Code information
- Lot 210806-015, exp 11/4/2021
- Postal code
- 63026-2394
- Report date
- Oct 20, 2021
- Product type
- Drugs
- Recall number
- D-0007-2022
- Classification
- Class II
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Product quantity
- 385 bags
- Termination date
- Dec 28, 2022
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1
- Distribution pattern
- MO
- Recall initiation date
- Sep 22, 2021
- Initial firm notification
- Center classification date
- Oct 8, 2021