A steamy shipping glitch has forced Novartis’ generics unit to yank a batch of deep vein thrombosis meds from U.S. shelves.
Sandoz is recalling one lot of enoxaparin sodium injection single-dose syringes after part of the batch was exposed to high temperatures during shipping. The balmy conditions may have “significantly impacted” the drug’s effectiveness, Sandoz said in a notice posted on the FDA’s website. The heat exposure raises a “reasonable probability of risk for patients with health conditions that the product is intended to treat,” the company added.
As of Wednesday, Sandoz said it hadn’t received any safety reports linked to the recall.
Enoxaparin is used to prevent deep vein thrombosis (DVT), plus complications associated with heart attacks, Sandoz said. DVT occurs when a blood clot forms in a deep vein. This usually happens in the legs and can occur after surgeries or in patients whose mobility is limited during an illness.
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Patients are at risk of developing blood clots if they take a less effective version of Sandoz’s drug, the company said. Those clots in turn can cause pain, swelling, stroke, clots to the lung or even death because of a patient’s underlying condition, Sandoz said.
The enoxaparin batch in question was manufactured on May 26 and shipped out nationwide in September and October, Sandoz said. The recall covers one lot of a 40-mg dose in 0.4-mL single-dose syringes. The product comes in cartons of ten single-dose syringes. Sandoz didn’t say how many cartons were in the affected lot.
The company stressed that the recall is confined to a single batch, and that no other strengths of its enoxaparin sodium injection were affected.
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The recall comes as Sandoz’s parent company Novartis weighs its options for the generic drugmaker.
Novartis in October kicked off a strategic review of the unit, which could result in a spinoff or separation. It wouldn’t be uncharted territory for the industry: Both Merck and Pfizer recently converted their generics outfits into the standalone public-listed companies Organon and Viatris, respectively.
