FDA recall D-1141-2017

Product

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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2017-08-22

Report date

2017-09-20

Termination date

2020-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, AL, United States

Primary source

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