Medications & Supplements/Over-the-Counter

Centurion Labs, LLC: Ninjacof and Ninjacof-A Recalled for Potential Bacterial Contamination

Agency Publication Date: September 12, 2017

Summary

Centurion Labs, LLC is recalling 4,770 bottles of Ninjacof (Chlophedianol HCL and Pyrilamine Maleate) and Ninjacof-A (Acetaminophen, Chlophedianol HCL, and Pyrilamine Maleate) cotton candy flavored oral solutions. The recall was initiated because the products may be contaminated with Burkholderia cepacia, a type of bacteria that can cause serious infections. These 16 fl. oz. (473 mL) bottles were distributed nationwide to pharmacies and healthcare providers.

Risk

The products may contain the bacteria Burkholderia cepacia, which poses a significant risk of infection, especially for individuals with compromised immune systems or chronic lung conditions such as cystic fibrosis. These infections can be difficult to treat and may lead to serious health complications.

What You Should Do

Check your Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) 16 fl. oz. bottles for Lot 200N1601 with an expiration date of 11/2018 (NDC 23359-032-16).
Check your Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) 16 fl. oz. bottles for Lot 201NA1601 with an expiration date of 11/2018 (NDC 23359-033-16).
Stop using the affected medication immediately and contact your healthcare provider or pharmacist for guidance regarding alternative treatments.
Return any unused product to the pharmacy where it was purchased for a refund and contact Centurion Labs, LLC for further instructions.
Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution (16 fl. oz. / 473 mL)

Model:

NDC 23359-032-16

Recall #: D-1140-2017

Lot Numbers:

200N1601 (Exp. 11/2018)

Date Ranges: 11/2018

Product: Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution (16 fl. oz. / 473 mL)

Model:

NDC 23359-033-16

Recall #: D-1141-2017

Lot Numbers:

201NA1601 (Exp. 11/2018)

Date Ranges: 11/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77990

Status: Resolved

Manufacturer: Centurion Labs, LLC

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 2 products (4149 bottles; 621 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) 16 fl. oz. bottles for Lot 200N1601 with an expiration date of 11/2018 (NDC 23359-032-16).

Check your Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) 16 fl. oz. bottles for Lot 201NA1601 with an expiration date of 11/2018 (NDC 23359-033-16).

Stop using the affected medication immediately and contact your healthcare provider or pharmacist for guidance regarding alternative treatments.

Return any unused product to the pharmacy where it was purchased for a refund and contact Centurion Labs, LLC for further instructions.

Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution (16 fl. oz. / 473 mL)

Model:

NDC 23359-032-16

Recall #: D-1140-2017

Lot Numbers:

200N1601 (Exp. 11/2018)

Date Ranges: 11/2018

Product: Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution (16 fl. oz. / 473 mL)

Model:

NDC 23359-033-16

Recall #: D-1141-2017

Lot Numbers:

201NA1601 (Exp. 11/2018)

Date Ranges: 11/2018