A little less than a year after Apotex found itself mixed up in sweeping recalls for the popular diabetes drug metformin, the company is yanking two batches of an injectable anticoagulant.
Apotex pulled one 100-mg/mL batch of enoxaparin sodium injection and one 120-mg/0.8-mL batch after a customer complaint investigation revealed some syringe barrels bore the wrong measurement markings.
The packaging error led to certain 120-mg/0.8-mL concentrations of the anticoagulant turning up in syringes with 100 mg/mL markings, while some 100 mg doses wound up in 150-mg-marked syringes.
The affected batches were manufactured by Hyderabad, India-based Gland Pharma, according to the FDA’s posting. As of Thursday, Apotex hadn’t received any side effect reports linked to the suspect products, Jordan Berman, VP, global corporate affairs, business transformation and strategic planning at the company, said over email.
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“Apotex and its manufacturing partners are committed to delivering high-quality products to our customers and patients,” he said, adding that the company had launched the recall in partnership with its contract manufacturing partner.
In fact, it was Apotex’s CMO that received the customer complaint and initiated the investigation, he explained.
The batches made their way to wholesalers and warehousing units across the U.S. before Apotex issued the voluntary recall. The 100-mg/mL units were set to expire in April of 2022, while the 120-mg/0.8-mL units were meant to be good until May of that same year, Berman said.
The FDA’s recall notice doesn’t cover the total number of syringes included in the recall, though it states that both batches consist of packs of 10 single-dose syringes.
Enoxaparin, an anticoagulant, is used to treat and prevent deep vein thrombosis and is also used to treat heart attacks.
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The packaging mix-up could cause patients to receive more or less of the drug than they bargained for if a miscalculation leads to the wrong dose being delivered, Apotex warned. Enoxaparin overdose can cause bleeding complications, while receiving less of the drug than prescribed might lead to blood clotting.
The company is reaching out to wholesalers and warehouses to get the products back. Meanwhile, patients should stick with their therapy, contact their healthcare provider for advice and immediately return any syringes from the recalled batches, Apotex said.
Apotex last year was one of many drugmakers caught up in a spate of recalls after the FDA identified the likely carcinogen N-Nitrosodimethylamine (NDMA) in samples of the popular diabetes med metformin.
The regulator in May pushed five companies to pull their extended-release metformin products from shelves. Apotex ranked among them, alongside Actavis, Amneal, Lupin and Marksans. Apotex initially yanked one lot of the drug before it broadened its recall to cover all lots of metformin hydrochloride extended-release tablets in the U.S.
