Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72
Affected NDC
0904-6980-72
Compare with the code on your package — it is the most precise check available.
Drug: Guaifenesin
- Recalling firm
- Plastikon Healthcare LLC
- NDC code
- 0904-6980-72
- Origin
- KS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1491-2022 · 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 Plastikon Healthcare LLC
All 2022 recalls
Class II · Moderate risk
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
CORRECTDOSE Children's ALLERGY RELIEF
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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