Class II
Terminated
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.
- Company
- Tris Pharma Inc.
- Recall Initiated
- July 11, 2019
- Posted
- July 31, 2019
- Recall Number
- D-1517-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,550 bottles
- Firm Location
- Monmouth Junction, NJ, United States
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.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot#: 14079, Exp 10/2021
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