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.
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.
Lot numbers, UPCs & expiration codes
Lot#: 14079, Exp 10/2021
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1517-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 2,550 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tris Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1517-2019, exactly as published.
Show all FDA fields
- City
- Monmouth Junction
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83346
- Address
- 2033 US Highway 130
- Code information
- Lot#: 14079, Exp 10/2021
- Postal code
- 08852-3003
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1517-2019
- Classification
- Class II
- Recalling firm
- Tris Pharma Inc.
- Product quantity
- 2,550 bottles
- Termination date
- Nov 2, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jul 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 24, 2019