Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Product Mix-up
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDC
27808-0086-02
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocodone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release Hydrocodone Polistirex and Chlorpheniramine Polistirex NDC 27808-0086 |
HYDROCODONE BITARTRATE 10 mg/5mL; CHLORPHENIRAMINE MALEATE 8 mg/5mL | Suspension, Extended Release Oral |
Cranbury Pharmaceuticals, LLC | Rx · CII |
- Recalling firm
- Tris Pharma Inc.
- NDC code
- 27808-086-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1517-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydrocodone recalls
See all
Class III · Low risk
Hydrocodone Bitartrate and Homatropine Methlybromide tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Other recalls by Tris Pharma Inc.
All 2019 recalls
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
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