FDA recall D-1522-2016

Product

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-08-08

Report date

2016-10-05

Termination date

2024-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1522-2016