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Recall Observatory FDA recall evidence

Drug product

MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX

D-1563-2014

December 19, 2013

Class I

Product summary

Firm
Abrams Royal Pharamacy
Event
Event 67135
Status
Terminated
Classification
Class I
Quantity
74
Official record key
drug-enforcement:D-1563-2014

Official wording

Reason: Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis

Code information: Lot number 11142013@74

Distribution pattern: Nationwide and to Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis