Officials with PharmaTech, LLC have recalled a number of products, including antihistamines and liquid syrups because of a possible Burkholderia cepecia contamination
According to a company announcement posted on the US Food and Drug Administration’s page, “if a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at risk patient population”.
Company officials wrote in the announcement that they are notifying customers through letters, and as of yet, they “have not received any complaints to date of contamination in the products and the associated lot numbers.”
Affected products include liquid items produced from October 20, 2015 through July 15, 2016, including, but not limited to: Diocto and Senexion liquid products from Rugby, Senna Syrups from Major, Aller-chlor Antihistamine and Sennazon Syrup from Bayshore, Ninjacof from Centurion, and Virtrate-2, Sodium Citrate-Citric Acid, from Virutus, among others. A complete list is available on the FDA website.
Adverse events related to use of these products should be reported to the FDA at www.fda.gov/medwatch/report.htm.