Hydrocodone Polistirex And Chlorpheniramine Polistirex Suspension, Extended Release
FDA Recall NDC 27808-086
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Hydrocodone Polistirex And Chlorpheniramine Polistirex (NDC 27808-086). A significant event, classified as Class II, was initiated on Jul 11, 2019 by Cranbury Pharmaceuticals, Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
July 2019 Class II Recall: Superpotent Drug and Failed Stability Specifications
Recall Number
Class II Terminated
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.
Jul 11, 2019
Jul 31, 2019
2,550 bottles
Recall Profile & Regulatory Data
Event ID
83346
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Tris Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Nov 02, 2021
Product Description
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
27808-086-02Product
27808-086-01Product
27808-086-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
