Safety alertSource: FDA Drug Enforcement Reports

Class II recall: American Regent, Inc.: niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a)

American Regent, Inc. issued a Class II recall of niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), supplied in 10 mL single dose vials and 10x10 mL single dose vial packs, manufactured for Civica, Inc. The recall notice states the product was contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde.

Most relevant for: patients requiring nicardipine hydrochloride injection for acute hypertension management or acute coronary syndromes

Read the original at FDA Drug Enforcement Reports

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