FDA recall D-1540-2014

Product

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

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2014-01-10

Report date

2014-08-27

Termination date

2015-07-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1540-2014