Glenmark, Baxter issue separate recalls for hypertension and cancer drugs

2023-08-28

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来源: FiercePharma

Glenmark USA and Baxter Healthcare issue separate voluntary recalls for blood pressure tables and an injectable cancer drug, respectively.

Glenmark Pharmaceuticals USA and Baxter Healthcare issued separate recalls citing out-of-specification tests and problems with labels for drugs used to treat hypertension and cancer, respectively.

Both recalls are designated as Class III, meaning the products in question violate federal regulations but are unlikely to cause adverse health consequences.

Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets used to treat high blood pressure. In a notice, the company said an assay test at the three-month time point found the drug to be subpotent.

The company produced the medicine at one of its sites in India. The tablets had been distributed nationwide in the U.S.

Baxter, meanwhile, recently issued a voluntary recall for 13,502 vials of bendamustine HCl injection, which is used to treat cancers such as lymphoma and chronic lymphocytic leukemia.

The drug is being recalled after a customer complaint flagged issues with labels falling off the vials.

India-based Glenmark is no stranger to FDA scrutiny and recalls. Late last year, an FDA warning letter flagged issues with batch failures, lab controls, record-keeping and more at a site in Colvale, India. A separate assay test by the company had prompted a prior recall in June 2022.

As for Baxter, the company recently sold its biopharma solutions unit to private equity firms Warburg Pincus and Advent International in a $4.25 billion deal. That standalone company just named a new CEO in Franco Negron.

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