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

FDA recall notice · announced September 21, 2016 · Hospira

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

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.
Lot/code information: Lot #: 52175DD, Exp 01 Oct 2016
Quantity: 24000 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.