AvKARE, Pulaski, TN announced on December 9, 2020 that it is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled “due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility.”
Sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor, is used for the treatment of erectile dysfunction and is packaged in 100 count bottles, NDC 42291-748-01. Trazodone hydrochloride is indicated for the treatment of major depressive disorder and packaged in 1000 count bottles, NDC 42291-834-10. The affected lots of 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) were distributed to AvKARE’s distributors and wholesalers, and then further distributed nationwide.
Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues. For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. Unintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision. These adverse events may be more concerning in elderly patients due to a subsequent increased risk for falls and driving impairment. To date, AvKARE has not received any reports of adverse events related to this recall. AvKARE has notified its distributors and customers and is arranging for return of all recalled product of the listed lots.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 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.
AvKARE states on its website: “AvKARE is your complete and trusted healthcare distributor of Pharmaceuticals and Infection Control products. We are a family oriented organization and believe wholeheartedly that our people drive the success of our company. With these beliefs in mind, and with eyes focused always on our goal of supporting our customers, AvKARE continues to grow into the thriving company it is today … In addition to supporting our governmental agencies, AvKARE’s clientele includes commerical partners and vendors across the globe. AvKARE provides infection control products and pharmaceuticals to many commercial facilities. AvKARE strives to provide our respected commercial customers with high quality and competitively priced products.”
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