|Articles|February 18, 2014

Ben Venue Laboratories Issues Voluntary Recall Of Acetylcysteine Solution

Author(s)Melanie Sena

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.


Related to this article

Regulatory Roundup—September 2026
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.