D-1141-2017 Class II Terminated

Recalled by Centurion Labs, LLC — Birmingham, AL

Recall Details

Product Type
Drugs
Report Date
September 20, 2017
Initiation Date
August 22, 2017
Termination Date
September 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
621 bottles

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

Distribution Pattern

Nationwide.

Code Information

Lot: 201NA1601 Exp. 11/2018