FDA 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.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-07-11

Report date

2019-07-31

Termination date

2021-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monmouth Junction, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2019