PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 5, 2016 Initiated: August 8, 2016 #D-1522-2016

Product Description

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.

Details

Recalling Firm
Pharmatech LLC
Units Affected
1,332 bottles
Distribution
Nationwide
Location
Davie, FL

Frequently Asked Questions

What product 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.. Recalled by Pharmatech LLC. Units affected: 1,332 bottles.
Why was this product recalled?
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 5, 2016. Severity: Moderate. Recall number: D-1522-2016.