Recalls / Class II
Class IID-1500-2016
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
- Affected lot / code info
- Lot #: 52175DD, Exp 01 Oct 2016
Why it was recalled
Discoloration: Firm received complaints of product discoloration and particulates.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 24000 vials
- 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.
Timeline
- Recall initiated
- 2016-08-15
- FDA classified
- 2016-09-14
- Posted by FDA
- 2016-09-21
- Terminated
- 2019-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1500-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.