D-502-2013 Class II Terminated
FDA drug recall D-502-2013 was initiated by Hospira Inc. on Apr 30, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. The recall status is terminated (terminated Oct 8, 2014). Affected quantity: 44,748 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 12, 2013
- Initiation Date
- Apr 30, 2013
- Termination Date
- Oct 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,748 bags
Product Description
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Reason for Recall
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 11-309-KL
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-502-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026