HHP Medication Safety Watch: November 2024

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This list contains selected items from the full FDA list of recalls, withdrawals, and alerts for medicines and certain health products. We've provided links to FDA information for each product and its maker. Unless otherwise noted, these actions apply only to the specific brand name of the product listed. Talk to your healthcare provider before stopping or changing any medicines or treatments that they have recommended for you.


Over-the-counter products and medicines

Dietary supplement recalled due to prescription drug contamination

Comment: Some lots of these products were recalled after FDA testing revealed contamination with the prescription drugs sildenafil and diclofenac.

Sildenafil is prescribed for erectile dysfunction. It can cause serious side effects, including a dangerous drop in blood pressure. This risk is highest among people who are also taking heart medicines such as nitroglycerin. A sudden and significant drop in blood pressure may cause heart attack, stroke, or death.

Diclofenac is a non-steroidal anti-inflammatory (NSAID) pain relief medicine. It can cause serious side effects, including stomach ulcers, kidney damage, cardiovascular disease, and allergic reactions. Diclofenac may cause dangerous interactions with other medicines. People with cardiovascular, gastrointestinal, or kidney disease, and those taking blood thinners (such as warfarin) or other NSAIDs, are more likely to experience these problems.

The recalled products are sold as dietary supplements for male sexual performance and energy.

Dietary supplement for pain relief recalled due to contamination with prescription drugs

  • Umary hyaluronic acid tablets, 850 mg (distributor: MXBBB)

Comment: The maker of this product recalled one lot after FDA testing revealed contamination with two other drugs, diclofenac and omeprazole.

Diclofenac is a prescription anti-inflammatory drug used to treat arthritis and other painful or inflammatory conditions. It can cause gastrointestinal and cardiovascular side effects, and kidney or liver damage. It may cause dangerous interactions with other medicines.

Omeprazole is a proton pump inhibitor (PPI) used to treat acid-related stomach conditions, including ulcers. Possible side effects include allergic reactions, diarrhea, and headache. It can also interact with other medicines. In addition, omeprazole may mask serious stomach disorders such as ulcers or cancer.

This product is sold as a dietary supplement for a number of proposed health benefits, including joint and skin health.


Prescription medicines

Clonazepam recall expands due to incorrect dosage information

  • Par Pharmaceutical clonazepam orally disintegrating tablets (maker: Endo, Inc.)

Comment: The maker of this product has expanded its previous recall to include additional lots due to incorrect dosage information on the label. For example, the packaging may list the dosage as 1 mg when the tablets contain 2 mg. Taking a higher than intended dose of clonazepam can cause dizziness, sedation, and confusion. In people with lung disease or who already take a high dose of this medicine, life-threatening breathing difficulties may develop.

This medicine is approved to treat panic disorder and certain types of seizures.


Read additional issues of HHP Medication Safety Watch

Disclaimer:

As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles.

No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.

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