FDA recall D-1378-2012

Luitpold Pharmaceuticals, Inc. · Class II · drug

Product

CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.

Reason for recall

Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.

Distribution

Nationwide, Puerto Rico, and Abu Dhabi

Key facts

Status: Terminated
Initiation date: 2011-03-15
Report date: 2012-06-20
Termination date: 2018-06-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Shirley, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1378-2012