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Hypertension Drug Recalled
Teva Pharmaceuticals Inc is recalling 2 lots of Matzim LA (diltiazem hydrochloride) extended-release tablets for failing to meet dissolution specifications. According to the August 10, 2022, US Food and Drug Administration (FDA) Enforcement Report, samples from the lots tested below specification limits for dissolution.
The recall affects the following products, which were manufactured by Actavis Laboratories, Fort Lauderdale, FL, and distributed by Actavis Pharma Inc, Parsippany, NJ, throughout the United States and Puerto Rico:
- Matzim LA extended-release tablets, 180 mg, 30-count bottle (NDC 52544-691-30), from lot 1411593A (Exp. 9/22); and
- Matzim LA extended-release tablets, 240 mg, 30-count bottles (NDC 58544-692-30), from lot 1411596A (Exp. 9/22).
Teva Pharmaceuticals voluntarily initiated the recall July 21, 2022. On August 4, 2022, the FDA designated the recall Class II, signaling use of the tablets could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Matzim LA is a prescription calcium channel blocker used to treat high blood pressure.