Why it was recalled
Lack of sterility assurance
Product description
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
Lot numbers, UPCs & expiration codes
Lot #: 20170509@6, Exp 6/23/2017; 20170519@35, Exp 7/3/2017; 20170523@22, Exp 7/7/2017; 20170525@9, Exp 7/9/2017; 20170605@49, Exp 7/20/2017; 20170605@9, Exp 7/20/2017
Where it was sold
LA, PA, NY, WI
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-0977-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 21, 2017
- FDA report date
- Jul 19, 2017
- Quantity
- 660 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0977-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 77600
- Address
- 8821 Knoedl Ct
- Code information
- Lot #: 20170509@6, Exp 6/23/2017; 20170519@35, Exp 7/3/2017; 20170523@22, Exp 7/7/2017; 20170525@9, Exp 7/9/2017; 20170605@49, Exp 7/20/2017; 20170605@9, Exp 7/20/2017
- Postal code
- 72205-4600
- Report date
- Jul 19, 2017
- Product type
- Drugs
- Recall number
- D-0977-2017
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 660 bags
- Termination date
- Apr 3, 2019
- Reason for recall
- Lack of sterility assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
- Distribution pattern
- LA, PA, NY, WI
- Recall initiation date
- Jun 21, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 13, 2017