July 2019 FDA Recall Hydrocodone Polistirex And Chlorpheniramine Polistirex by Tris Pharma Inc.
D-1517-2019 - Superpotent Drug and Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Tris Pharma Inc. on July 11, 2019 for the product Hydrocodone Polistirex And Chlorpheniramine Polistirex. The FDA reported the reason for recall as superpotent drug and failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1517-2019

Reason for Recall
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.
Initiated
07-11-2019
Reported
07-31-2019
Quantity
2,550 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83346
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tris Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-02-2021
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 14079, Exp 10/2021

Affected Packages Involved in this Recall

27808-086-02 Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release
27808-086-01 Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release
27808-086-03 Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release