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.
Reported: October 5, 2016 Initiated: August 8, 2016 #D-1522-2016
Product Description
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.
Reason for Recall
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Details
- Recalling Firm
- Pharmatech LLC
- Units Affected
- 1,332 bottles
- Distribution
- Nationwide
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pharmatech LLC. Units affected: 1,332 bottles.
Why was this product recalled? ▼
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 5, 2016. Severity: Moderate. Recall number: D-1522-2016.
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