Recalls / Class II
Class IID-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.
- Brand name
- Hydrocodone Polistirex And Chlorpheniramine Polistirex
- Generic name
- Hydrocodone Polistirex And Chlorpheniramine Polistirex
- Active ingredients
- Chlorpheniramine Maleate, Hydrocodone Bitartrate
- Route
- Oral
- NDC
- 27808-086
- FDA application
- ANDA091632
- Affected lot / code info
- Lot#: 14079, Exp 10/2021
Why it was recalled
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.
Recalling firm
- Firm
- Tris Pharma Inc.
- Manufacturer
- Cranbury Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2033 US Highway 130, N/A, Monmouth Junction, New Jersey 08852-3003
Distribution
- Quantity
- 2,550 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2019-07-11
- FDA classified
- 2019-07-24
- Posted by FDA
- 2019-07-31
- Terminated
- 2021-11-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1517-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.