Bedford Laboratories is recalling one lot of acetylcysteine, which is often used to treat acetaminophen overdoses, after glass particles were found in a vial.
The acetylcysteine solution recall was announced publicly February 2, but hospitals were notified of the problems December 20.
While the recall was originally limited to hospitals, it has now been extended to the patient level, in case there are patients who have the drug. However, there have been no reports of injuries or adverse effects associated with the recall vials.
Acetylcysteine is used to prevent liver injury after someone has suffered an overdose of Tylenol or its active ingredient, acetaminophen. It is also given as an inhalant to treat abnormal or thick mucous secretions.
Inhaled glass particles from a vial of the drug could cause airway obstruction that may result in patients choking, wheezing, coughing, contracting infections and suffering other complications, some of which could be life-threatening.
The recall affects one lot of Acetylcysteine Solution, USP, 20% in 30 mL vials. The vials are from Lot 1877093 with NDC #0054-3026-02. They have an expiration date of June 2013. They were manufactured by Roxane Laboratories, Inc. and distributed by Bedford Laboratories.
Patients are advised to check the lot number and return the drug to their pharmacist if it is one of the vials that have been recalled. The recall calls for hospitals, emergency rooms, clinics and doctors’ offices not to use the product for patient care and advises them to quarantine affected vials for return.
Patients and customers with questions can call GENCO Pharmaceutical Services at (800) 950-5479 and select menu option 1. The recall calls for adverse events to be reported to the FDA’s MedWatch adverse event reporting program.