D-1540-2014 Class I Terminated
FDA drug recall D-1540-2014 was initiated by Hospira Inc. on Jan 10, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. The recall status is terminated (terminated Jul 14, 2015). Affected quantity: 123,900 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 27, 2014
- Initiation Date
- Jan 10, 2014
- Termination Date
- Jul 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123,900 vials
Product Description
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02
Reason for Recall
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot # 27-352-DK; Exp 03/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1540-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026