IGMPI India

The FDA announces that Ben Venue Laboratories Inc. of Bedford, Ohio has issued a nationwide voluntary product recall for Acetylcysteine Solution 10 Percent, USP, (Manufactured for Roxane Laboratories, Inc.) 10Percent, 30 ml per vial – NDC #0054-3025-02 – Lot 2005479 – Exp. Date March 2014.

Acetylcysteine is a drug used primarily as mucolytic agent. Acetylcysteine solution is used in treatment of chronic emphysema and chronic asthmatic bronchitis and so is delivered via Nebulizer for inhalation and during bronchoscopy, it can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree. So any glass particle in solution can cause airway blockage and pose a risk of choking, wheezing or infection. The recall is being processed by Genco Pharmaceutical Services. Acetylcysteine administered orally, is an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

This was a voluntary recall due to discovery of a single visible glass particle in a vial within the lot listed above. It was a voluntary nationwide patient level recall and is limited to the one lot number listed above. No complaint regarding a piece of glass in vial of this lot has been made earlier. And all other product parameters were within the specifications.

Hospitals, emergency rooms, clinics, physician offices, and other healthcare facilities and providers should not use the product of this lot for patient care and should immediately quarantine any product for return. The company has been asking patients who received the product from this one lot to return it to their pharmacist. Ben Venue Laboratories has informed the FDA of its actions and is maintaining ongoing discussion with the agency. This nationwide voluntary recall is being conducted with the knowledge of the FDA.