Recalls / Class II
Class IID-0976-2017
Product
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
- Affected lot / code info
- Lot #: 20170509@2, Exp 6/23/2017; 20170524@22, Exp 7/8/2017; 20170602@10, Exp 7/17/2017; 20170609@27, Exp 7/24/2017
Why it was recalled
Lack of sterility assurance
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 221 bags
- Distribution pattern
- LA, PA, NY, WI
Timeline
- Recall initiated
- 2017-06-21
- FDA classified
- 2017-07-13
- Posted by FDA
- 2017-07-19
- Terminated
- 2019-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0976-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.