Summary

Company Announcement Date:
December 09, 2020
FDA Publish Date:
December 09, 2020
Product Type:
Drugs
Reason for Announcement:
Due to product mix-up
Company Name:
AvKare
Brand Name:
AvKare
Product Description:
Sildenafil 100 mg tablets and Trazodone 100mg tablets

Company Announcement

AvKARE, Pulaski, TN 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.

Product

Lot

Expiration date

Bottle count

NDC Number

Sildenafil Tablets, USP 36884 03/2022 100 42291-748-01
Trazodone Tablets, USP 36783 06/2022 1000 42291-834-10

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.

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 our distributors and wholesalers, and then further distributed nationwide.

Read the full report here.
As published by HealthyExaminer.com