Drug recall D-1517-2019
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.
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.
Lots and codes
Lot#: 14079, Exp 10/2021
Recall details
- Recalling firm
- Tris Pharma Inc., Monmouth Junction, NJ
- Quantity
- 2,550 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 11, 2019
- Terminated
- November 2, 2021
Related products
- Hydrocodone Polistirex and Chlorpheniramine Polistirex – drug information
- NDC 27808-086 Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release · Hydrocodone Bitartrate 10 mg/5mL; Chlorpheniramine Maleate… · Cranbury Pharmaceuticals, LLC