FDA-Drug2016-09-21Class II

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

Hospira Inc.
Hazard

Discoloration: Firm received complaints of product discoloration and particulates.

Sold states
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.
Affected count
24000 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1500-2016

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