Apotex issues recall of eye treatment over cracked bottle caps

Generics manufacturer Apotex is voluntarily pulling six lots of its brimonidine tartrate ophthalmic solution off the shelves after cracks were reported on some bottle caps.

Broken caps can impact the sterility of the product, and even lead to a potential adverse event, the company said. The drug is used to reduce intraocular pressure for patients with open-angle glaucoma or ocular hypertension, and affected batches were distributed across the US between April 5 of last year and Feb. 22, 2023.

Apotex has been notifying wholesalers, warehouses and pharmacies of the recall and is arranging for the return of any recalled product. The FDA’s recall report states that patients who have received the drug or have questions should contact their pharmacy and notify their healthcare provider for medical advice.

Jordan Berman

In an email to Endpoints News, Jordan Berman, VP of corporate global affairs, business transformation and strategy at Apotex, said that there have been “no drug safety reports related to negative health outcomes due to this product.”

Apotex has issued a few recalls in the past. In 2021, the manufacturer recalled three lots of the ADHD treatment guanfacine due to trace amounts of quetiapine fumarate in one of the lots, the consumption of which could lead to a drop in blood pressure, sleepiness and dizziness.

The manufacturer also launched a voluntary recall of two batches of the blood thinner injection enoxaparin sodium in 2021 after discovering that some syringes were mislabeled and could possibly lead to patients getting more of the drug than needed.

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