Class II recall: American Regent, Inc.: ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR

The FDA has classified as Class II a recall by American Regent, Inc. of Acetylcysteine Solution, USP, 20% (200 mg/mL), supplied in 4 mL vials (NDC 0517-7604-01) and 25x4 mL vial packs (NDC 0517-7604-25), labeled not for injection. The recall notice states the product was found to be contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde.

Most relevant for: patients requiring treatment for acetaminophen overdose or other conditions managed with acetylcysteine who may have received the recalled contaminated product from American Regent, Inc.

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