Recalls / Class II
Class IID-1521-2016
Product
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.
- 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 #: 25291601, Exp 03/18
Why it was recalled
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recalling firm
- Firm
- Pharmatech LLC
- Manufacturer
- Centurion Labs, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4131 Sw 47th Ave, Suite 1403, Davie, Florida 33314-4026
Distribution
- Quantity
- 5,928 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-08
- FDA classified
- 2016-09-27
- Posted by FDA
- 2016-10-05
- Terminated
- 2024-09-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1521-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.