February 07, 2012

Bedford Laboratories Issues Recall of Acetylcysteine Solution, USP, LOT 1877093

The Missouri Department of Health and Senior Services received the following updated guidance on the recall of Acetylcysteine Solution originally initiated on December 20, 2011. The original recall was initiated after the discovery of a single visible glass particle in a vial.

The specifications of the product include:
Acetylcysteine Solution, USP, (Manufactured for Roxane Laboratories, Inc.) 20%, 30 mL per vial - NDC #0054-3026-02 - Lot 1877093 - Exp. Date June 2013

Acetylcysteine for inhalation is usually delivered via a Nebulizer, but can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchosopy. Glass particles can cause airway obstruction resulting in symptoms of choking, wheezing, difficulty breathing, coughing and potentially hemoptysis.

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lot listed above for patient care and should immediately quarantine any product for return.

Patients that may have received product dispensed from this one lot should return the product to their pharmacist. Distributors/retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI 53218.

The full recall announcement can be found at www.fda.gov/Safety/Recalls/ucm290204.htm?source=govdelivery.