Drug Safety Alerts

AvKARE Sildenafil 100mg tablets and Trazodone 100mg tablets Consumer-Level Recalls

12/08/2020

On December 8, 2020, AvKARE issued consumer-level recalls of Sildenafil 100mg tablets and Trazodone 100mg tablets. This recall was issued due to these products being inadvertently packaged together during bottling at a 3rd party facility.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

A complete list of the affected products is provided here.

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 recommends that 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.

CVS Caremark® Response: Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies.

For more information, please call AvKARE Customer Service at 1-855-361-3993. You may also call the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.