Erectile Dysfunction, Depression Drugs Recalled Nationwide After Packaging 'Mix-Up'

AvKARE is recalling both its erectile dysfunction drugs and depression pills following a mix-up in its third party packing facility that resulted in the two medications being packed together. Consuming these products unintentionally may cause serious health risks in some people.

As the announcement posted on the U.S. Food and Drug Administration (FDA) website explained, sildenafil is the active ingredient in Viagra, and people with underlying medical issues may experience adverse reactions after accidentally consuming the drug.

"For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels," the company announcement said. "Consumers with diabetes, high blood pressure, or heart disease often take nitrates."

On the other hand, trazodone is classified as a serotonin modulator. It is used to treat depression. Sometimes, it is also used as a medication for schizophrenia and insomnia, said Medline Plus. According to the company announcement, unintended consumption of trazodone may cause dizziness, blurred vision, constipation and sedation.

The mentioned health effects are problematic particularly for older people who may accidentally take the drugs, the company announcement explained.

Further, patients taking trazodone run the risk of experiencing withdrawal symptoms such as anxiety and agitation if they suddenly stop taking it. This is why Medline Plus advises those using it to first consult their physician before deciding to stop using the drugs.

Affected Products

The recall affects one lot each of AvKARE's 100 mg Sildenafil tablets and 100 mg Trazodone tablets to the consumer level with the following specifications:

• Sildenafil Tablets, USP Lot 36884 with expiration date 03/2022 in 100 count bottles; NDC Number 42291-748-01
• Trazodone Tablets, USP Lot 36783 with expiration date 06/2022 in 1,000 count bottles; NDC Number 42291-834-10

These products were reportedly distributed nationwide, and the company has since contacted its customers and distributors to return the affected products.

No adverse reactions related to the recall have been reported so far, the announcement said.

Those with questions about the recall may call the company's customer service at 1-855-361-3993 or via email at customerservice@avkare.com to return the product.

"Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax," the FDA said, also noting that the consumers should contact their healthcare provider if they experience adverse effects from using the products.