Richland, Mississippi-based Centurion Labs withdrew lots of Ninjacof and Ninjacof A last week.
In the recall notice the firm states the withdrawn products were “manufactured by Vilvet (Dania Beach, FL).”
However, Centurion also says it “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.”
Neither Centurion nor the US FDA responded to requests for more information ahead of publication.
In an email Vilvet told us it “is not a manufacturer and did not manufacture any products for Centurion” adding that it “is strictly a distribution company.”
The firm also said: “To our knowledge, the correct manufacturer that should be listed in the recall notification is Pharmatech LLC” adding it is not affiliated with Pharmatech or Centurion and suggesting “there was a misrepresentation in the original press release by Centurion.”
Burkholderia cepacia concerns
Earlier this month the US FDA warned doctors not to use any drugs made by PharmaTech citing Michigan–based Rugby Laboratories’ withdrawal of two products - Diocto Liquid and Diocto Syrup – that had been made on its behalf by the Florida CMO.
The agency said the Centers for Disease Control and Prevention (CDC) had detected a strain of B. cepacia linked to recent infections in the Rugby products and recommended that “health care professionals and patients not use PharmaTech’s liquid drug products.”