Ninjacof Solution
FDA Recall NDC 23359-032
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ninjacof (NDC 23359-032). A significant event, classified as Class II, was initiated on Aug 22, 2017 by Centurion Labs, Llc. The reported reason for this action was: "Microbial contamination of Non-sterile Products; potential B. cepacia contamination"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2017 Class II Recall: Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Recall Number
Class II Terminated
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Aug 22, 2017
Sep 20, 2017
4149 bottles
Recall Profile & Regulatory Data
Event ID
77990
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Centurion Labs, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Sep 14, 2020
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
Batch or Lot Expiration Information
Lot# Lot: 200N1601 Exp. 11/2018
Affected Packages Involved in this Recall
23359-032-16Product
23359-032-10Product
23359-032-04Product
Class II Terminated
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Aug 08, 2016
Oct 05, 2016
5,928 bottles
Recall Profile & Regulatory Data
Event ID
74874
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pharmatech LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 23, 2024
Product Description
Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16.
Batch or Lot Expiration Information
Lot# : 25291601, Exp 03/18
Affected Packages Involved in this Recall
23359-032-16Product
23359-032-10Product
23359-032-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
