PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: August 27, 2014 Initiated: January 10, 2014 #D-1540-2014

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
123,900 vials
Distribution
Nationwide and Puerto Rico.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 123,900 vials.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 27, 2014. Severity: Critical. Recall number: D-1540-2014.