Ninjacof-A 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-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (…

Recall number

D-1141-2017

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-A (Acetaminophen 160 mg, 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 23359-033-16