Canada’s biggest generic drug maker is no stranger to regulatory rebukes from the U.S. Now, after eluding FDA scrutiny for several years, Apotex has found its way back onto the agency’s recall list.
Apotex on Wednesday kicked off a recall of six lots of the glaucoma and ocular hypertension drug brimonidine tartrate ophthalmic solution. The company is acting “out of an abundance of caution” after it found cracks on the caps of certain brimonidine tartrate bottles. Those cracks could jeopardize the drug’s sterility, potentially paving the way for unwanted side effects, Apotex said in a release.
Apotex did not specify whether it had received any patient complaints or safety signals tied to the recall.
The med is an alpha-adrenergic receptor agonist used to help lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The recall exclusively pertains to brimonidine tartrate in the 0.15% presentation from Apotex.
The company is reaching out to wholesalers, distributors, warehouses and pharmacies to track down the affected bottles. The half-dozen brimonidine tartrate batches were shipped out across the U.S. between April 2022 and February 2023.
Apotex has enjoyed a relatively good run ever since it charted a pair of recalls in early 2021. In February of that year, Apotex pulled one lot of the anticoagulant enoxaparin. A few weeks later in April, Apotex yanked three lots of 2-mg guanfacine extended-release tablets, used to treat attention-deficit/hyperactivity disorder.
Back in 2019, meanwhile, Apotex withdrew 31 of its generic drug approvals from the FDA after the regulator pinpointed manufacturing issues at two plants in India.
Apotex’s fate was thrown into flux with the murder of the company’s founder Barry Sherman and his wife in 2017. Last September, following a CEO switch and a price fixing settlement, the company sold itself to private investment firm SK Capital.
At the time of the sale, the terms of which remain under wraps, Apotex employed roughly 8,000 people across more than 100 countries. Beyond Canada and the U.S., Apotex boasts a significant footprint in India and Mexico. Back in 2019, the company was valued at around $3 billion.