FDA recall D-1500-2016

Hospira Inc. · Class II · 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

Reason for recall

Discoloration: Firm received complaints of product discoloration and particulates.

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2016-08-15
Report date: 2016-09-21
Termination date: 2019-08-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

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