Multi event Drug Recall Enforcement Report Class II voluntary initiated by Centurion Labs, LLC, originally initiated on 08-22-2017 for the 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 The product was recalled due to microbial contamination of non-sterile products; potential b. cepacia contamination. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1141-2017 | 08-22-2017 | 09-20-2017 | Class II | 621 bottles | 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 | Microbial contamination of Non-sterile Products; potential B. cepacia contamination | Terminated |
| D-1140-2017 | 08-22-2017 | 09-20-2017 | Class II | 4149 bottles | 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 | Microbial contamination of Non-sterile Products; potential B. cepacia contamination | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 23359-032 | Ninjacof | Chlophedianol Hcl And Pyrilamine Maleate | Solution | Oral | Centurion Labs, Llc | Human Otc Drug |
