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Recall Observatory FDA recall evidence

Drug product

DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20

D-1500-2016

August 15, 2016

Class II

Product summary

Firm
Hospira Inc.
Event
Event 74707
Status
Terminated
Classification
Class II
Quantity
24000 vials
Official record key
drug-enforcement:D-1500-2016

Official wording

Reason: Discoloration: Firm received complaints of product discoloration and particulates.

Code information: Lot #: 52175DD, Exp 01 Oct 2016

Distribution pattern: Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units. 30 units returned by customer and destroyed internally.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulates