Drug 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
D-1141-2017
Product summary
- Event
- Event 77990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 621 bottles
- Official record key
drug-enforcement:D-1141-2017
Official wording
Reason: Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Code information: Lot: 201NA1601 Exp. 11/2018
Distribution pattern: Nationwide.
Derived failure modes
-
Microbial contamination
Microbial contamination