D-1517-2019 Class II Terminated
FDA drug recall D-1517-2019 was initiated by Tris Pharma Inc. on July 11, 2019 and is designated Class II. 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 t… The recall status is terminated (terminated November 2, 2021). Affected quantity: 2,550 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- July 11, 2019
- Termination Date
- November 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,550 bottles
Product Description
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 Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot#: 14079, Exp 10/2021