FDA-Drug2017-09-20Class II

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

Centurion Labs, LLC
Hazard

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

Sold states
Nationwide.
Affected count
621 bottles
Manufactured in
3100 Bowling Dr, Suite 1, Birmingham, AL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1141-2017

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