Tris Pharma Recalls Hydrocodone and Chlorpheniramine Suspension Due to Potency Issues
Tris Pharma is recalling 2,550 bottles of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension due to high out-of-specification results for active ingredients and preservatives.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.
Plain-English summary
Tris Pharma Inc. is recalling 2,550 bottles of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension. The product is a prescription-only oral suspension equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL, packaged in 16 fl. oz. (473 mL) bottles. The specific lot number is 14079 with an expiration date of 10/2021.
The recall was initiated because of superpotent drug levels and failed stability specifications. Specifically, the active ingredients hydrocodone and chlorpheniramine, as well as the preservatives, showed high out-of-specification results. This means the medication may contain higher amounts of the active drugs than intended, which could pose a risk to patients.
The affected product was distributed nationwide in the USA and Puerto Rico. Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX)
- Brand
- HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
- Manufacturer
- Tris Pharma Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 2,550
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 14079
- Exp 10/2021
UPCs (1)
- 0327808086013
Distribution
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