Particulate Matter Leads to Indomethacin, Sodium Chloride Recalls

One lot of American Regent’s concentrated sodium chloride injections and one lot of Bedford Laboratories’ Indomethacin injections have been recalled due to contamination by particulate matter. 

The drug recalls were announced earlier this week by the FDA. The indomethacin injections have particles of an active drug ingredient that can be seen floating in them, but the particulate matter in the sodium chloride vials was not identified in the recall announcement. There have been no illnesses reported in connection to either drug recall.

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) used to treat a congenital heart disorder in children known as patent ductus arteriosus, when a newborn’s ductus arteriosus fails to close after birth. It is also used to treat arthritis and as a painkiller. The Indomethacin injection recall warns that the particles could cause an immune reaction or result in microinfarcts due to particles clogging capillaries and small arteries.

Sodium chloride is essentially table salt. It is given in concentrated form to patients with problems taking in electrolytes or with other unusual fluid needs. The concentrated sodium chloride injection recall warns that the particles could disrupt blood flow within small blood vessels in the lung, which could lead to localized inflammation and granuloma formation.

The American Regent drug recall affects lot 0362 of Concentrated Sodium Chloride Injection, USP, 23.4% in 30 mL single dose vials. They have an expiration date of May 2012 and NDC # 0517-2930-25.

The Bedford Laboratories drug recall affects lot 1948138 of Indomethacin Injection, USP, in 1 mg single dose vials. They have an expiration date of September 2011 and NDC # 55390-299-01.

Hospitals and other health care facilities with affected vials of these drugs on hand should quarantine them immediately. Both companies have agreed to take back any remaining stock and credit accounts of customers who return any vials from the affected lots. American Regent customers with questions can call 1-877-788-3232. Bedford Laboratories customers with questions can call 1-800-562-4797 or email the company at Indomethacinrecall1948138.cle@boehringer-ingelheim.com.