FDA MedWatch - Sildenafil 100 mg Tablets and Trazodone 100 mg Tablets by AvKARE: Recall - Due to Product Mix-Up

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Sildenafil 100 mg Tablets and Trazodone 100 mg Tablets by AvKARE: Recall - Due to Product Mix-Up AUDIENCE: Consumer, Patient, Health Professional, Risk Manager, Pharmacy  ISSUE: AvKARE is recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility.  The affected lots of Sildenafil 100 mg tablets (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 distributors and wholesalers, and then distributed nationwide. Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues, it 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. For product photos, lot and NDC numbers click the red button "Read Recall" below. BACKGROUND: 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.  RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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