WASHINGTON (dpa-AFX) - Generic drug maker AvKare, inc. recalled one lot each of Sildenafil 100 mg and Trazodone 100 mg tablets due to a product mix-up, the U.S. Food and Drug Administration said in a statement. The company said the two separate products were inadvertently packaged together during bottling at a third party facility.
The generic drug maker is calling back lot number 36884 of Sildenafil Tablets, USP packaged in 100 count bottle, with expiration date of March 2022 and lot number 36783 of Trazodone Tablets, USP packaged in 100o count bottle, with expiration date of June 2022.
However, the company said it is yet to receive any reports of adverse events related to the products involved in the recall. The two drugs were distributed to distributors and wholesalers, and then further distributed across the U.S.
Sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor, is used for the treatment of erectile dysfunction. Trazodone hydrochloride is indicated for the treatment of major depressive disorder.
According to the company, the unintentional consumption of Sildenafil due to the mix up may pose serious health risks to consumers with underlying medical issues. Sildenafil may interact with nitrates found in some prescription drugs, lowering blood pressure to dangerous levels.
Meanwhile, the inintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision. It could lead to increased risk for falls and driving impairment particularly in elderly patients.
AvKARE has notified its distributors and customers on the recall. It urged distributors that have any of the recalled products to contact Customer Service at AvKARE to arrange for the return of the product, the company added.
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