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Recall Observatory FDA recall evidence

Drug product

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61

D-0778-2016

December 31, 2015

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 72973
Status
Terminated
Classification
Class III
Quantity
Unavailable
Official record key
drug-enforcement:D-0778-2016

Official wording

Reason: Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Code information: Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent