American Regent Sodium Chloride Recall: Particulate Contamination

Visible particles found floating in vials has led to a recall of 21 lots of concentrated sodium chloride injections made by American Regent. 

The sodium chloride recall was announced on March 15 by the FDA after the manufacturer discovered the problem and pulled the injections.

American Regent, Inc. says it has identified the source of the particulates and has made changes to correct the issue, however the company did not identify what the particles were made of, or how they got into the sodium chloride injections.

According to the company, the particulates could disrupt blood flow in the lung, and cause localized inflammation and granuloma formation. There have been no reports of illness or injury reported in connection to the contaminated sodium chloride injections.

The recall affects 16 lots of concentrated sodium chloride injection, USP 23.4% in 30 mL single dose vials with NDC# 0517-2930-25. Also being recalled are 5 lots of concentrated sodium chloride injection, USP 23.4% in 100 mL pharmacy bulk packages with NDC# 0517-2900-25. A complete list of lot numbers, expiration dates and distribution dates is available on the recall notice .

Concentrated sodium chloride injections are used to treat patients that have problems taking in or excreting sodium electrolytes.

This is the third recall of American Regent injectable drugs this year due to particulate contamination. In early January, the company issued an Acetadote recall affecting six lots. In early February one lot of sodium thiosulfate was recalled after flakes of glass were found in some vials.

American Regent says it will credit accounts for all customers affected by the recall. Healthcare providers or patients with questions should contact American Regent’s Professional Services Department at 1-877-788-3232. Anyone experiencing an adverse reaction is asked to report the problem to American Regent Inc. via e-mail at PV@luitpold.com. Adverse reactions should also be reported to the FDA’s MedWatch program online at www.fda.gov/medwatch/report.htm.