D-1140-2017 Class II Terminated
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