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Recall Observatory FDA recall evidence

Drug product

Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas

D-0940-2016

April 18, 2016

Class II

Product summary

Firm
Baptist Health Medical Towers Pharmacy and Infusion Services
Event
Event 73899
Status
Terminated
Classification
Class II
Quantity
7 bags
Official record key
drug-enforcement:D-0940-2016

Official wording

Reason: Lack of Sterility Assurance

Code information: All product remaining within expiry

Distribution pattern: Arkansas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility