CLASS II Drug recall · Reported 5 Oct 2016 · FDA Enforcement Report
Ninjacof-A (acetaminophen, chlophedianol HCl recalled by Pharmatech
Pharmatech is recalling Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5, distributed nationwide in the US. The recall was initiated on 8 Aug 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1522-2016
- FDA event ID
- 74874
- Recalling firm
- Pharmatech, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2016
- FDA classified
- 27 Sep 2016
- Reported
- 5 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 8 Aug 2016 | Recall initiated by company | |
| 27 Sep 2016 | Classified by FDA | +50 days |
| 5 Oct 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Which lots are affected?
Lot #: 25321601, Exp 04/18
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 74874This product is part of a recall event; the main page for the event is Diocto Syrup (docusate sodium), 60 mg recalled by Pharmatech.
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Other Ninjacof-a (acetaminophen recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ninjacof-A (Acetaminophen 160 mg recalled by Centurion Labs | Centurion Labs | Sterility | Nationwide |