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Public Alert No. 036/2020- AvKARE Recalls Sildenafil 100MG Tablets And Trazodone 100mg Tablets Due To Product Mix Up During Bottling

December 18, 2020,

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 major depressive disorder. Unintended intake of trazodone may result in adverse health consequences.

Product Details

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

 

100mg

Recommendations

NAFDAC implores 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 your healthcare provider for alternative treatment. 

Patients and healthcare providers are advised to report adverse events and quality problems they experienced using these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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