Class III · Low risk Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical…
Reason Superpotent; sodium benzoate preservative
Is Guaifenesin recalled?
78 FDA recalls mention Guaifenesin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Guaifenesin.
Class II · Moderate risk Terminated
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10…
Reason CGMP Deviations: Released product should have been rejected.
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN…
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN…
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Ongoing
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further…
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III · Low risk Ongoing
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further…
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II · Moderate risk Ongoing
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican…
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…
Class II · Moderate risk Ongoing
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Class II · Moderate risk Terminated
Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL…
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer…
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v)…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I · High risk Terminated
G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal…
Reason Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class III · Low risk Terminated
NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT…
Reason Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class II · Moderate risk Terminated
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL)…
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional…
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For…
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class III · Low risk Terminated
Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd…
Reason Incorrect/Undeclared Excipient: Product contains alcohol
Class II · Moderate risk Terminated
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc…
Reason CGMP Deviations
Class II · Moderate risk Terminated
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk…
Reason CGMP Deviations
Class II · Moderate risk Terminated
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select…
Reason cGMP deviations
Class II · Moderate risk Terminated
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl…
Reason cGMP deviations
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