Safety alertSource: FDA Drug Enforcement Reports

Class II recall: American Regent, Inc.: Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials

The FDA reports a Class II recall of American Regent's nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), distributed in 10 mL vials (NDC 0517-4810-01) and 25x10mL vial packs (NDC 0517-4810-25). The recall was initiated due to the presence of particulate matter in the product, identified as hair, glass, and/or paraformaldehyde, according to the FDA notice.

Most relevant for: patients receiving nitroglycerin injection for acute cardiovascular conditions who may have received the affected product batches

Read the original at FDA Drug Enforcement Reports

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