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Guaifenesin FDA Alerts

The FDA Alerts below may be specifically about guaifenesin or relate to a group or class of drugs which include guaifenesin.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for guaifenesin

FDA Advises Consumers Not to Use Rompe Pecho Cough Syrup

Oct 11, 2019 | Audience: Consumers

October 11, 2019 -- FDA advises consumers not to use Rompe Pecho EX and Rompe Pecho CF cough syrups distributed by Efficient Laboratories, Inc., Miami, Florida, due to microbial contamination risks. These are over-the-counter medicines for children six years and older. FDA recommends consumers stop using these medicines and dispose of them. These contaminated cough medicines could potentially cause illness.

On October 9, 2019, FDA recommended that Efficient Laboratories recall Rompe Pecho EX and Rompe Pecho CF cough syrups. To date, the company has not taken action to remove these potentially dangerous medicines from the market.

FDA is not aware of any reports of adverse events associated with these medicines at this time. Consumers who use Rompe Pecho EX and Rompe Pecho CF cough syrups and have concerns should contact their health care professional.

FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program: 

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178

Source: FDA

Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup

Jan 13, 2016 | Audience: Consumer

Including store brands:

  • Sunmark  
  • Rite-Aid  
  • Topcare  
  • Kroger  
  • GoodSense  
  • Dollar General
  • Care One  
  • CVS

ISSUE: Perrigo Company announced that, following the recent recall of certain dosing cups by its supplier, it has initiated a voluntary product recall in the US to the retail level of 2 batches of its children's guaifenesin grape liquid (100mg/5 mL) and 3 batches of its children's guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles with dosage cup in a box under multiple store brand product names. Some packages contain an oral dosing cup with incorrect dose markings. See the press release for affected label and lot numbers.

At risk populations such as those who are poor metabolizers of dextromethorphan may experience an overdose by a factor of 3, if incorrect measuring levels are used.

Consumers should be aware that an overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma. Other effects have included nausea, vomiting, tachycardia, irregular heartbeat, seizures, respiratory depression, and death. Small children who are poor metabolizers of dextromethorphan and use the product regularly over a period of several days at the mistaken dose, may develop cumulative toxicity. Moreover, adverse reactions to guaifenesin when given in high or excessive dosage may include nausea/vomiting, diarrhea, and/or abdominal pain. Therefore, an extreme overdose in an at risk population may need medical intervention, but in most cases adverse health consequences are temporary and reversible.

BACKGROUND: These recalled products are sold by distributors nationwide and distributed through retail stores.

RECOMMENDATION: Gastric decontamination is recommended after acute ingestion of greater than 10 mg/kg, if administered soon after ingestion.

Consumers that have product with the corresponding labels and batch numbers listed in the Press Release should discard the dosing device and product and may call Perrigo, toll free, Monday through Friday from 8:00 AM to 10:00 PM EST, at 1-888-345-0479, or visit mucusreliefrecall.com. Consumers should contact their physician or healthcare provider if they have any questions, or if they or their children experience any problem that could possibly be related to this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[01/11/2016 - Press Release - Perrigo]

Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets

Dec 13, 2010 | Audience: Consumer, Pharmacist

Refenesen Expectorant (guaifenesin 200 mg tablets)
Select Brand Mucus Relief Expectorant (guaifenesin 200 mg)
QC Medifin Expectorant (guaifenesin 200 mg)
Leader Cough Tabs Expectorant (guaifenesin 200 mg)

ISSUE: Reese Pharmaceutical Company has voluntarily recalled lot# 091612 only in 60-count size bottles identified under four different brand names: Refenesen Expectorant (guaifenesin 200 mg tablets), Select Brand Mucus Relief Expectorant (guaifenesin 200 mg), QC Medifin Expectorant (guaifenesin 200 mg), and Leader Cough Tabs Expectorant (guaifenesin 200 mg) because cold decongestant tablets (containing Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg) were mislabeled as containing only 200mg Guaifenesin tablets.

BACKGROUND: The mislabeled product does not warn consumers that Acetaminophen may cause liver damage. Ingesting high doses of Acetaminophen can potentially cause severe liver damage. The likelihood of acute liver damage is higher among consumers with pre-existing liver disease and those who drink three or more alcoholic drinks per day. Overdose may specially occur if consumers are also taking other cold/cough products that contain Acetaminophen in addition to the mislabeled product. Contraindications for Phenylephrine are high-blood pressure, poor blood flow to the extremities, and patients on antidepressants known as MAO Inhibitors. Furthermore, products that contain Phenylephrine should be used with caution in patients with high blood pressure, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or enlarged prostate. Consumers who are allergic to any of the ingredients or who have narrow angle glaucoma, or are pregnant or nursing mothers, also should not take the product.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[12/08/2010 - Press Release - Reese Pharmaceutical]

    

Guaifenesin (Unapproved) Timed-Release Drug Products

May 25, 2007 | Audience: Consumers, healthcare professionals[Posted 05/25/2007] FDA informed consumers and healthcare professionals of its intent to take action against companies that market unapproved timed-release dosage form of guaifenesin products, a substance commonly used in medicines to relieve cough and cold symptoms by stimulating removal of mucous from the lungs. These dosage forms are often described as extended-release, long-acting or sustained-release products that release their active ingredients over an extended period of time, reducing the number of doses needed per day. Approximately 20 firms make unapproved timed-release products containing guaifenesin that have not undergone FDA review for safety and efficacy. Mucinex, Mucinex-D, Mucinex-DM, and Humibid are the only FDA approved timed-release guaifenesin (single ingredient or combination) products. Companies marketing unapproved products containing guaifenesin in timed-release form are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days. This action does not affect products containing guaifenesin in immediate release form.

[May 25, 2007 - News Release - FDA]


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