Ninjacof and Ninjacof A: Recall - Potential Burkholderia Cepacia Contamination

AUDIENCE: Consumer, Pharmacy

ISSUE: Centurion Labs is voluntarily recalling 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia.

Products are sold in 473 mL bottles with the expiration date of 11/2018. The affected products are Ninjacof with Lot# 200N1601 (NDC 23359-032-16) and Ninjacof A with Lot# 201NA1601 (NDC 23359-033-16) and both were distributed within the following states: Alabama, Arkansas, Florida, Georgia, Louisiana, Missouri, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, and Texas. See press release for product photos.

Use of a product that may contain 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 even life threatening in the at-risk patient population.

BACKGROUND: Ninjacof and Ninjacof A are used to temporarily relieve symptoms due to the common cold, allergic rhinitis or other respiratory allergies.

RECOMMENDATION: Centurion Labs is notifying its distributors and customers by recall letter. To date Centurion Labs has not found any B. cepacia or received any complaints for the products or lots listed. However, it is recommended that patients, pharmacies, and healthcare facilities that have the recalled product on hand stop their use immediately.

Consumers with questions regarding this recall can contact the company at Centurion Customer Support:recall@centurionlabs.com or 601-852-3681 (M-F 8am – 5pm Central Standard Time).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm572909.htm