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Recall Observatory FDA recall evidence

Drug product

Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

D-0925-2016

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
a) 10 bags, b) 23 bags, c) 9 bags, d) 6 bags
Official record key
drug-enforcement:D-0925-2016

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