D-1500-2016 Class II Terminated
FDA drug recall D-1500-2016 was initiated by Hospira Inc. on August 15, 2016 and is designated Class II. Reason for recall: Discoloration: Firm received complaints of product discoloration and particulates. The recall status is terminated (terminated August 23, 2019). Affected quantity: 24000 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 21, 2016
- Initiation Date
- August 15, 2016
- Termination Date
- August 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24000 vials
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.
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.
Code Information
Lot #: 52175DD, Exp 01 Oct 2016