Recalls / Class II
Class IID-1140-2017
Product
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
- Brand name
- Ninjacof
- Generic name
- Chlophedianol Hcl And Pyrilamine Maleate
- Active ingredients
- Chlophedianol Hydrochloride, Pyrilamine Maleate
- Route
- Oral
- NDC
- 23359-032
- FDA application
- M012
- Affected lot / code info
- Lot: 200N1601 Exp. 11/2018
Why it was recalled
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Recalling firm
- Firm
- Centurion Labs, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3100 Bowling Dr, Suite 1, Birmingham, Alabama 35242-6588
Distribution
- Quantity
- 4149 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2017-08-22
- FDA classified
- 2017-09-12
- Posted by FDA
- 2017-09-20
- Terminated
- 2020-09-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1140-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.