Ninjacof Oral Solution recalled over sterility concerns

Recall date

August 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Centurion Labs, LLC recalls Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Fl…

Recall number

D-1140-2017

FDA classification

Class II

Brand / firm

Centurion Labs, LLC

Sold / distributed

Nationwide.

Why it was recalled

Microbial contamination of Non-sterile Products; potential B. cepacia contamination

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16