Drug product
Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/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 23359-033-16.
D-1522-2016
Product summary
- Firm
- Pharmatech LLC
- Event
- Event 74874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,332 bottles
- Official record key
drug-enforcement:D-1522-2016
Official wording
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Code information: Lot #: 25321601, Exp 04/18
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations