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
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
particulates