American Pharmaceutical distributor, AvKare, is recalling its Sildenafil 100mg tablets and Trazodone 100mg tablets due to “product mix-up.”
Sildenafil is the generic name for Viagra, which is a PDE-5 inhibitor used to treat erectile dysfunction.
National Agency for Food and Drug Administration and Control (NAFDAC), which confirmed the presence of this “mix-up” product in Nigeria, added that “unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues.”
NAFDAC said in a statement that it was informed of the development by the United States Food and Drug Administration (FDA).
NAFDAC said 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,” the statement said.
The Nigerian drug regulator 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 also encouraged patients already using the affected drugs to discontinue using the medication and consult their 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 firstname.lastname@example.org,” the statement added.