Centurion Labs pulls products over Burkholderia cepacia concerns

By Staff reporter

- Last updated on GMT

Recalled Centurion  products (source FDA website)
Recalled Centurion products (source FDA website)
Centurion Labs has recalled two lots of cold and allergy meds after the US FDA warned they may have been made at a Pharmatech LLC plant linked to a Burkholderia cepacia outbreak.

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In the recall notice the firm states the withdrawn products were “manufactured by Vilvet (Dania Beach, FL).”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​.”

Related topics: Regulatory & Safety, Regulations, QA/QC

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