Concentrated Sodium Chloride Injection 23.4% from American Regent - Recall Due to Particulates
March 21, 2011
American Regent is voluntarily recalling multiple lots of concentrated sodium chloride injection 23.4%, 30 mL single dose vials and 100 mL pharmacy bulk packages. Vials of the affected lots may contain visible particulates. Solutions containing particulates may pose a safety risk if administered to patients. The following products are affected by this recall:
- Sodium chloride 23.4% injection, 30 mL single dose vials, NDC #0517-2930-25: lot #9198 (expires 3/31/2011), lot #9252 (expires 4/30/2011), lot #9299 (expires 4/30/2011), lot #9305 (expires 5/31/2011), lot #9402 (expires 6/30/2011), lot #9423 (expires 6/30/2011), lot #9432 (expires 6/30/2011), lot #9553 (expires 8/31/2011), lot #9595 (expires 8/31/2011), lot #9646 (expires 9/30/2011), lot #9681 (expires 10/31/2011), lot #9737 (expires 10/31/2011), lot #9797 (expires 11/30/2011), lot #9831 (expires 12/31/2011), lot #0051 (expires 1/31/2012), lot #0095 (expires 2/28/2012)
- Sodium chloride 23.4% injection, 100 mL pharmacy bulk package, NDC #0517-2900-25: lot #9225 (expires 4/30/2011), lot #9492 (expires 7/31/2011), lot #9711 (expires 10/31/2011), lot #0007 (expires 01/31/2012), lot #0058 (expires 1/31/2012)
Avoid administering the affected products and immediately quarantine the recalled vials for return to the manufacturer. Visually assess all parenteral drug products before administration and discard if particulates and color changes are present.
Healthcare providers with questions may contact American Regent at 1-877-788-3232, weekdays from 8:30AM to 7:00PM Eastern Standard Time. American Regent will credit accounts for all returned products from the affected lots. To report adverse effects from the use of any of the recalled lots, contact American Regent at PV@luitpold.com, 1-800-734-9236 (phone), 1-610-650-0170 (fax), or 1-610-650-7781 (fax); or report adverse events to FDA’s MedWatch program.
Additional information is available at the following links:
- MedWatch Alert:
- Firm Press release:
- Photographs of vial labels:
March 21, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.