PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 21, 2016 Initiated: August 15, 2016 #D-1500-2016

Product Description

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
24000 vials
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.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 24000 vials.
Why was this product recalled?
Discoloration: Firm received complaints of product discoloration and particulates.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 21, 2016. Severity: Moderate. Recall number: D-1500-2016.