Class II recall: American Regent, Inc.: AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL M

American Regent, Inc. has issued a Class II recall for Aminocaproic Acid Injection, USP, 250 mg/mL (5 g/20 mL), distributed in 20 mL multiple dose vials (NDC 0517-9120-01) and 25x20 mL multiple dose vial packs (NDC 0517-9120-25). According to the recall notice, the product was found to be contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde.

Most relevant for: Patients undergoing cardiac surgery or procedures requiring aminocaproic acid for hemostasis who may have received the contaminated product from the affected lot.

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