PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 20, 2017 Initiated: August 22, 2017 #D-1141-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Centurion Labs, LLC
Units Affected
621 bottles
Distribution
Nationwide.
Location
Birmingham, AL

Frequently Asked Questions

What product 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. Recalled by Centurion Labs, LLC. Units affected: 621 bottles.
Why was this product recalled?
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Which agency issued this recall?
This recall was issued by the FDA Drug on September 20, 2017. Severity: Moderate. Recall number: D-1141-2017.