Tris Pharma Inc. is recalling 2,550 bottles of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL). This prescription cough and cold medication is being recalled because testing revealed the product is superpotent, meaning it contains higher levels of the active ingredients and preservatives than specified. Consumers should contact their healthcare provider or pharmacist immediately, as using a superpotent drug can lead to serious adverse health effects.
The drug contains excessive amounts of hydrocodone and chlorpheniramine, which increases the risk of overdose symptoms such as extreme drowsiness, respiratory depression, or other toxic effects from the high levels of active ingredients and preservatives.
Healthcare provider consultation and pharmacy return.
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.
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.