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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-0484-2015

February 18, 2015

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 70549
Status
Terminated
Classification
Class II
Quantity
25 vials
Official record key
drug-enforcement:D-0484-2015

Official wording

Reason: Crystallization

Code information: NDC 61786-0055-01, Lot # B00484449-100914, Lot # B0062349-121914, Lot # B006655-011415; Expiration Date: 04/01/2016

Distribution pattern: PA, OK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Crystallization