FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Postmarket Safety

Mylan Recalls Two Injectable Drugs Made in India

April 8, 2015

Mylan is recalling two injectables — a hypertension drug and cancer treatment — due to quality control issues. Both drugs were manufactured in India.

On Jan. 23, the drugmaker recalled 78,090 vials of nicardipine hydrochloride injection, 25 mg/10 ml, due to potential subpotency and failed specifications for impurities and degradation.

The recall, cited in a recent FDA enforcement report, involves single dose vials of the blood pressure medication.

Mylan initiated a second recall on Feb. 11 of 936 vials of cancer treatment doxorubicin hydrochloride injection because ifosfamide injection may have been mispackaged in a carton labeled with the drug. — Jonathon Shacat