Centurion Labs is recalling two lots of its cold and allergy medication Ninjacof manufactured by Vilvet of Dania Beach, Florida, and distributed by Centurion Labs because the products may be contaminated with Burkholderia cepacia, a bacteria that can be serious or even life threatening to some individuals. The recall was initiated after Centurion was notified by the Food and Drug Administration (FDA) regarding the potential contamination after the agency discovered the product may have been manufactured in a Pharmatech facility in Davie, Florida, the manufacturing company at the center of several medication recalls.
Use of a product that contains B. cepacia 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 deadly for at-risk patient populations.
The recall involves one lot of Ninjacof from Lot number 200N1601 with the NDC 23359-032-16, and one lot of Ninjacof A from Lot number 201NA1601 with the DNC 23359-033-16. Both products are sold in 473 mL bottles with the expiration date of 11/2018. They were distributed within Alabama, Arkansas, Florida, Georgia, Louisiana, Missouri, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee and Texas.
Ninjacof and Ninjacof A are used to temporarily relieve symptoms due to the common cold, allergic rhinitis or other respiratory allergies. To date, Centurion Labs has not found any B. cepacia or received any complaints for products or lots affected by this recall. However, the company is recommending that patients, pharmacies and health care facilities with the recalled products stop using them immediately.
Any adverse events related to these recalled products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice