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Ben Venue issues a voluntary patient level recall of Acetylcysteine Solution 10% due to glass particle in vial.
Ben Venue Laboratories has issued a nationwide voluntary patient level recall of Acetylcysteine Solution 10%, USP, Lot 2005479 after the discovery of a single visible glass particle in a vial. There have been no complaints or adverse events related to a piece of glass in vials of this lot. All other product parameters were within specifications, according to a company statement. The recall is limited to a single lot number.
Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.
Source: Ben Venue Laboratories