US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 11, 2019 (7 years ago)

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.

What was recalled

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.

Recalling firm
Tris Pharma Inc.
NDC code
27808-086-02
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1517-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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