D-1140-2017 Class II Terminated

Recalled by Centurion Labs, LLC — Birmingham, AL

FDA drug recall D-1140-2017 was initiated by Centurion Labs, LLC on Aug 22, 2017 and is designated Class II. Reason for recall: Microbial contamination of Non-sterile Products; potential B. cepacia contamination The recall status is terminated (terminated Sep 14, 2020). Affected quantity: 4149 bottles.

Recall Details

Product Type
Drugs
Report Date
Sep 20, 2017
Initiation Date
Aug 22, 2017
Termination Date
Sep 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4149 bottles

Product Description

Ninjacof (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 23359-032-16

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Lot: 200N1601 Exp. 11/2018

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1140-2017
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-1140-2017. Report a data issue: hello@regdatalab.com.