AvKARE bottles mix Viagra generics with antidepressant, triggering recall

Tablets in hand
In late 2019, Amneal bought a 65.1% stake in AvKARE—a generic drugmaker that supplies meds to the departments of Defense and the Veterans Affairs, among others. (Pixabay)

A generic drugmaker with a Rolodex full of federal clients is pulling an antidepressant and an erectile dysfunction med after the two were packaged together in the same bottles.

Pulaski, Tennessee-based AvKARE recalled one lot of sildenafil 100-mg tablets and one lot of trazodone 100-mg tablets after the products were mixed up by a third-party packaging supplier, the company said late last week. The bottles had already been shipped to pharmacies.

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AvKARE markets its own private-label generic drugs to a slate of government clients, including the departments of Defense, Veterans Affairs and the Health and Human Services. The company also supplies the Indian Health Services, plus nongovernment customers around the globe.

The consumer-level recall affects lots deployed to distributors and wholesalers and then shipped out nationwide, the company said. The sildenafil lot has a March 2022 expiration date, while the trazodone lot expires in June 2022.

AvKARE said it so far hasn't received any side-effect reports from the recalled lots. Sildenafil—a generic version of Viagra—can mix poorly with nitrate-containing drugs for diabetes, high blood pressure or heart disease, potentially lowering blood pressure to dangerous levels.

The antidepressant trazodone hydrochloride, meanwhile, can cause drowsiness, dizziness, constipation and blurred vision, AvKARE warned. Those side effects pose a greater risk of falls and impaired driving in older customers who may have purchased the company's erectile dysfunction copycat.

The company recently caught the attention of fellow generic drugmaker Amneal, which picked up a 65.1% stake in AvKARE in late 2019. The deal set the enterprise value for AvKARE at $340 million, Amneal said.

Meanwhile, AvKARE follows in the footsteps of Mylan and Sun Pharma, which both pulled drugs from shelves in August after separate packaging scares. Mumbai-based Sun yanked one lot of 10-mg lisinopril tablets in the U.S. after 20-mg tablets of the popular blood pressure med were found in at least one bottle.

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Mylan, meanwhile, recalled two lots each of its 450 mg-per-9 ml injectable amiodarone and 1,000 mg-per-10 ml injectable tranexamic acid, citing the possibility that the drugs may have swapped cartons. And those are just two recent examples.

Israeli-American pharma Teva in 2013 faced a call from France's drug overseer, ANSM, to pull thousands of blister packs of furosemide when packages that should have contained the diuretic were instead found to contain the drugmaker's sleep aid Zopiclone. Deaths resulting from that mixup sent French inspectors to Teva's plant in Sens, Burgundy, to get to the bottom of the switch.