Ninjacof-A Liquid recalled over manufacturing violations

Recall date

August 8, 2016

Source

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

Official notice title

Pharmatech LLC recalls Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz…

Recall number

D-1522-2016

FDA classification

Class II

Brand / firm

Pharmatech LLC

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

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, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16.