FDA recall D-625-2013

Baxter Healthcare Corp. · Class II · drug

Product

5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015

Reason for recall

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Distribution

Nationwide & Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-05-21
Report date: 2013-07-10
Termination date: 2015-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-625-2013