A recall has been issued for the cold medication Ninjacof, amid concerns that some batches may be contaminated with Burkholderia cepacia, a serious and potentially life-threatening bacterium.
The Centurion Labs Ninjacof recall was announced by the FDA on August 22, after receiving notice from the manufacturer that certain products may have been exposed to C. cepacia bacterium. No illnesses have been reported in relation to the recall.
Ninjacof is an over-the-counter drug that is used to relieve symptoms such as cough, throat irritation, running nose, nose and throat itching, and itchy or watery eyes due to the common cold or other respiratory allergies.
The recall was prompted after Centurion Labs received a report from the manufacturing company Pharmatech, that a separate product in the Davie, Florida facility where Ninjacof was also manufactured was found to be contaminated with B. cepacia. Due to the potential cross contamination and the spread of the bacterium in the facility, Centurion Labs issued a safety recall.
Burkholderia cepacia is a group of complex bacteria that can be found in soil and water and is often resistant to many common antibiotics, posing an increased risk to those with weakened immune systems such as children and the elderly.
Although the bacterial infection poses no significant threat to healthy individuals, those with respiratory infections, specifically cystic fibrosis and chronic lung disease may be more susceptible to the bacteria and require immediate medical treatment.
The recalled Ninjacof products include Lot# 200N1601, with NDC 23359-032-16, and Ninjacof A products with Lot# 201NA1601 with NDC 23359-033-16. Both products were sold in 473 mL bottles and are marked with an expiration date of November 2018.
The recalled lots were manufactured by Pharmatech under the Centurion Labs brand name and were distributed for sale in Alabama, Arkansas, Florida, Georgia, Louisiana, Missouri, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, and Texas.
Pharmacies, healthcare facilities, and consumers are being asked to stop using the recalled medications immediately and to quarantine the product and contact Centurion Customer Support at 601-852-3681 or email them at firstname.lastname@example.org for questions regarding the recall.