The National Agency for Food and Drug Administration and Control has been informed by the U.S Food and Drug Administration that AvKARE has recalled Sildenafil 100mg tablets and Trazodone 100mg tablets due to product mix-up. The Sildenafil 100mg and Trazodone 100mg were inadvertently packaged together during bottling by a third-party facility.
Sildenafil is the generic name for Viagra, which is a PDE-5 inhibitor used to treat erectile dysfunction. Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues.
Trazodone hydrochloride is indicated for the treatment of the major depressive disorder. Unintended intake of trazodone may result in adverse health consequences.
|PRODUCT NAME||PRODUCT MANUFACTURER||LOTS||EXPIRY DATE||BOTTLE COUNT||NDC NUMBER||PACK SIZE|
|Sildenafil Tablets, USP||AvKARE||36884||03/2022||100||42291-748-01||100mg|
|Trazodone Tablets, USP||AvKARE||36783||06/2022||1000||42291-834-10
NAFDAC reportedly implored all importers, wholesalers, and retailers to immediately stop the importation, distribution, and use of the recalled lots of Sildenafil 100mg tablets and Trazodone 100mg tablets.
NAFDAC encourages Patients already using the affected lots of Sildenafil 100mg tablets and Trazodone 100mg tablets to discontinue using the medication and consult their healthcare provider for alternative treatment while advising patients and healthcare providers to report adverse events and quality problems they experienced using these products to the nearest NAFDAC office.