Erectile dysfunction and depression drugs recalled after factory ‘mix up’

Mix up was a result of third-party error, says drug-maker

AvKARE says it has not received any reports of people becoming unwell following error (FDA)

A Tennessee-based pharmaceutical company is recalling two drugs that got "mixed up" while being packaged in a factory.

AvKARE said on Wednesday its 100mg Sidenafil and 100mg Trazodone tablets were put in the same bottles due to a "third party" error.

Sidenafil is the main ingredient in Viagra, a medication used to treat erectile dysfunction, while Trazodone is used to treat depression.

Sidenafil may pose serious health risks to consumers with underlying medical issues and others who are not supposed to take it, AvKARE said in a statment.

Trazodone may result in adverse health consequences such as sedation, dizziness, constipation, and blurred vision, the company added.

AvKARE said it had not yet recieved any reports of people getting sick as a result of taking the wrong medication.

In a statement published on the US Food and Drug Administration's website, the company said it is recalling one batch of both products.  

Those affected are Sildenafil 100 mg tablet lot 36884 with an expiration date of 03/2022, and Trazodone Hydrochloride 100 mg tablet lot 36783 with an expiration date of 06/2022.

AvKARE said the drugs were "distributed to our distributors and wholesalers, and then further distributed nationwide".

The company “notified its distributors and customers and is arranging for return of all recalled product of the listed lots”.

Anyone who has an adverse reaction to taking either drug by mistake is being asked to contact the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.