Apotex recalled two batches of the anticoagulant enoxaparin after its contract manufacturer discovered it had packaged the drug in syringes with incorrect measurement markings.
Apotex pulled one 100-mg/mL batch of enoxaparin sodium injection and one 120-mg/0.8-mL batch after its CMO, Gland Pharma, received a customer complaint about the syringes.
Certain 120-mg/0.8-mL concentrations of the anticoagulant were packaged in syringes intended for 100-mg/mL concentrations, while some 100 mg/mL concentrations were put into in syringes marked for 150 mg/mL doses.
The Hyderabad, India-based CMO was tipped off to the packaging error and initiated an investigation, Jordan Berman, Apotex VP for global corporate affairs, business transformation and strategic planning at the company, said over email.
"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.
The batches had already been distributed when 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 bore an expiration date of May 2022, Berman said.
The FDA’s recall notice doesn’t state the total number of syringes included in the recall, though it says 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.
The packaging mix-up could cause patients to receive more or less of the drug than intended, 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 providers 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 in samples of the popular diabetes med metformin.
The regulator in May pushed five companies to recall their extended-release metformin products from shelves. Apotex ranked among them, alongside Actavis, Amneal, Lupin and Marksans. Apotex initially pulled one lot of the drug before it broadened its recall to cover all lots of metformin hydrochloride extended-release tablets in the U.S.
Editor's note: This story and headline was revised to clarify that the recalled batches were produced by Gland Pharma, Apotex's contract manufacturer.