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Hypertension Capsules Pulled

Mylan Pharmaceuticals is recalling 8159 bottles of diltiazem hydrochloride extended-release capsules, 180 mg, after samples failed to meet dissolution specifications during routine testing, according to the February 27, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects 100-count bottles (NDC 0378-5280-01) and 500-count bottles (NDC 0378-5280-05) from lot 3090167 (Exp. 10/19). The affected bottles were distributed throughout the United States.

Mylan Pharmaceuticals voluntarily initiated the recall February 13, 2019. Two days later, the FDA designated it Class III, suggesting use of the affected capsules is not likely to cause harm.  

Diltiazem hydrochloride is a prescription calcium channel blocker used to treat patients with hypertension and chest pain. 

Jolynn Tumolo

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