CLASS II Drug recall · Reported 20 Sep 2017 · FDA Enforcement Report
Ninjacof-A (Acetaminophen 160 mg recalled by Centurion Labs
Centurion Labs is recalling Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5, distributed nationwide in the US. The recall was initiated on 22 Aug 2017 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-1141-2017
- FDA event ID
- 77990
- Recalling firm
- Centurion Labs, Birmingham, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2017
- FDA classified
- 12 Sep 2017
- Reported
- 20 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 22 Aug 2017 | Recall initiated by company | |
| 12 Sep 2017 | Classified by FDA | +21 days |
| 20 Sep 2017 | 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
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Ninjacof-A (Acetaminophen 160 mg, 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 23359-033-16
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Which lots are affected?
Lot: 201NA1601 Exp. 11/2018
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
1 other product · FDA event 77990| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ninjacof (Chlophedianol HCL 12.5 mg recalled by Centurion LabsNinjacof | Centurion Labs | Sterility | Nationwide |
More recalls from Centurion Labs
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ninjacof (Chlophedianol HCL 12.5 mg recalled by Centurion LabsNinjacof | Centurion Labs | Sterility | Nationwide |
Other Ninjacof-a (acetaminophen recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ninjacof-A (acetaminophen, chlophedianol HCl recalled by Pharmatech | Pharmatech | Manufacturing (CGMP) Deviations | Nationwide |