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Recall Observatory FDA recall evidence

Drug product

EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY

D-1182-2016

May 13, 2016

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 74466
Status
Terminated
Classification
Class II
Quantity
24000 mL in Vials
Official record key
drug-enforcement:D-1182-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 151202-45, BUD: 05/30/16; Lot #: 160105-38, BUD: 07/03/16; Lot #: 160114-20, BUD: 07/12/16; Lot #: 160217-28, BUD: 08/15/16

Distribution pattern: U.S. Nationwide, Japan, and New Zealand.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility