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Recall Observatory FDA recall evidence

Drug product

Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02

D-1271-2016

April 20, 2016

Class II

Product summary

Firm
Pharmakon Pharmaceuticals, Inc.
Event
Event 73960
Status
Terminated
Classification
Class II
Quantity
40
Official record key
drug-enforcement:D-1271-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: All Sterile Compounded Products within Expiry

Distribution pattern: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility