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Recall Observatory FDA recall evidence

Drug product

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

D-0977-2017

June 21, 2017

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 77600
Status
Terminated
Classification
Class II
Quantity
660 bags
Official record key
drug-enforcement:D-0977-2017

Official wording

Reason: Lack of sterility assurance

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

Distribution pattern: LA, PA, NY, WI

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility