FDAFDA · Food and drugs·Recall number D-1517-2019
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.
Published July 31, 2019 · Recall initiated: July 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
- Manufacturer
- Tris Pharma Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- UPC
- 0327808086013
- Lot
- Lot#: 14079, Exp 10/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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