AvKARE, Inc., a Tennessee-based generic pharmaceutical manufacturer, has voluntarily recalled one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets due to a product mix-up.
There has been a mix-up of Sildenafil tablets and Trazodone tablets that were inadvertently packaged together during bottling at a third party facility.
Sildenafil, sold under the brand name Viagra, is a PDE-5 inhibitor, which is used for the treatment of erectile dysfunction (ED).
Trazodone hydrochloride, sold under the brand name Desyrel, is used for the treatment of a major depressive disorder.
The mixed-up lots of Sildenafil 100mg and Trazodone Hydrochloride 100mg “were distributed to our distributors and wholesalers, and then further distributed nationwide,” said AvKARE.
Accidental or unintentional intake of sildenafil may pose serious health risks to those who have underlying medical issues, such as heart disease and high blood pressure. Also, the accidental consumption of sildenafil by people who already use nitrates or alpha-blockers could lower blood pressure to potentially dangerous levels.
Unintended consumption of trazodone may also result in adverse health consequences, such as sedation, drowsiness, somnolence, constipation, and blurred vision. In older people, these drug reactions could be concerning because of the subsequent increased risk of accidental falls and driving impairment.
Until now, the company has not received any reports of adverse events related to this recall.
Meanwhile, AvKARE has been notifying all of its distributors and customers about the recall. It has also been arranging for return of all lots of recalled product.
Distributors should contact AvKARE through phone or email if they have any of the product that has been recalled so the company can arrange for the return of the product. People who have used the recalled products and who experience any kind of adverse events should contact their physician or healthcare provider.
