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Z-tuss DM FDA Alerts

The FDA Alert(s) below may be specifically about Z-tuss DM or relate to a group or class of drugs which include Z-tuss DM (dextromethorphan/guaifenesin/phenylephrine).

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. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for dextromethorphan/guaifenesin/phenylephrine

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

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]


Dextromethorphan

May 23, 2005

Audience: Healthcare professionals and consumers

FDA issued a Talk Paper to notify the public about the abuse of dextromethorphan (DXM), an ingredient found in many over-the-counter (OTC) cough and cold remedies. The agency is working with other health and law enforcement authorities to address this serious issue and warn the public of potential harm, after five recently reported deaths of teenagers that may be associated with the consumption of powdered DXM sold in capsules.

[May 20, 2005 - Talk Paper - FDA]

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