Class II recall: American Regent, Inc.: ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR

American Regent, Inc. issued a Class II recall of Acetylcysteine Solution, USP, 10% (100 mg/mL), packaged in 4 mL vials (NDC 0517-7504-01) and 25x4 mL vial cartons (NDC 0517-7504-25), both labeled Not for Injection. The recall notice states the product was found contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde.

Most relevant for: patients or healthcare providers using acetylcysteine solution administered through non-injection routes due to contamination with particulate matter

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