Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative
Pentrexcilina Jarabe NF
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.
Drug: Guaifenesin
- Recalling firm
- Opmx, LLC
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-300-2013 · 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 Guaifenesin recalls
See all
Class II · Moderate risk
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
CGMP Deviations: Released product should have been rejected.
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class III · Low risk
Kids' Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Other recalls by Opmx, LLC
All 2013 recalls
Class II · Moderate risk
Pentrexcilina
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.