Class II recall: American Regent, Inc.: Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, pack
American Regent, Inc. issued a Class II recall of Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), for intravenous use, packaged as single-dose vials (NDC 0517-6502-01 and 0517-6502-10). The recall notice states the product was found to be contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde.
Most relevant for: Neonates and other patients receiving intravenous selenious acid supplementation, such as those on parenteral nutrition.
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