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Ben Venue Recalls Acetylcysteine Solution

Feb. 18, 2014

Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP, after a single glass particle was found in just one vial of a lot of the drug, the company said Friday.

The recall comes almost exactly two years after Ben Venue subsidiary Bedford Labs recalled another lot of the same drug, after glass particles were found in a single vial. The drugmaker at the time was also embroiled in a recall of three lots of injectable cytarabine for elevated risks of sterility problems.

There have been no complaints or reports of adverse events related to the affected lot, Ben Venue said. The drugmaker is asking patients and healthcare providers to quarantine and return any vials from the lot.

Inhaled acetylcysteine is indicated as an adjuvant therapy for patients with abnormal, viscid or inspissated mucous secretion and can be administered via a nebulizer, a tracheostomy or directly into the bronchial-pulmonary tree during a bronchoscopy.

Parent company Boehringer Ingelheim made the decision to shutter its Bedford, Ohio, subsidiary in October, just a month after shutting down two of its older facilities. The closing, effective at the end of 2013, was due to the $1 million cost of Ben Venue’s remediation efforts.

Read the recall notice at www.fdanews.com/ext/resources/files/02/02-18-14-BenVenueRecall.pdf. — Lena Freund

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