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Recall Observatory FDA recall evidence

Drug product

KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01

D-0974-2015

April 23, 2015

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 71094
Status
Terminated
Classification
Class II
Quantity
25
Official record key
drug-enforcement:D-0974-2015

Official wording

Reason: Crystallization

Code information: Lot # B0069266-013015, Lot # B0069264-013015, Lot # B0066712-011415, EXP DATE 9/01/2016

Distribution pattern: PA and OK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Crystallization