Teva issued a voluntary recall for two lots of its hypertension drug Matzim LA (diltiazem hydrochloride) after testing found the extended-release tablets failed to dissolve correctly.
The recalled products were manufactured by Actavis Labs in Florida and were distributed across the U.S. and Puerto Rico. Both have expiration dates of September 2022.
The FDA reported the recall on its website.
Using the recalled tablets could result in adverse health consequences with possible serious harm, the company said. To date, Teva has not received any reports of patient issues related to the drug.
Back in 2019, Teva recalled one lot of the drug because it had been unintentionally distributed commercially, the FDA said at the time.
That same year, 2019, the Israel-based drugmaker was caught up in a wave of recalls with other manufacturers of the hypertension drug losartan that contained impurities believed to cause cancer. The cause of the impurities were traced back to tainted active pharmaceutical ingredients manufactured at Hetero Labs.
The API in those recalls contained N-Nitroso-N-methyl-4-aminobutyric acid above the FDA’s acceptable limit.