Ben Venue Laboratories, Inc. has recalled a lot of its Acetylcysteine Solution 10%, Usp, following detection of glass particulate in a vial of the inhalation medication, the U.S. Food and Drug Administration (FDA) announced. The lot involved was manufactured for Roxane Laboratories, Inc.
Acetylcysteine is normally delivered as an inhalation medication via Nebulizer and is also delivered by direct instillation into a tracheostomy or, during bronchoscopy, into the bronchial-pulmonary tree. The recalled Acetylcysteine is packaged in a 30 mL vial and bears the following information: NDC #0054-3025-02, Lot 2005479, and Exp. Date March 2014.
If glass particles are received with the medication during treatment, airway obstruction may result, causing an array of adverse health reactions: choking, wheezing, difficulty breathing, coughing, and hemoptysis (blood expectoration). When an inhaled product that contains glass particles is used, life-threatening choking may occur. When small glass particles enter the airways through aerosolization, recurrent infections due to airway obstruction and decreased airway secretion clearance may occur.
Acetylcysteine is approved for adjuvant therapy in patients who are diagnosed with abnormal, viscid, or inspissated (very thick) mucous secretion. Acetylcysteine is administered orally and is also approved to prevent or minimize hepatic (liver) injury, which may follow ingestion of a potentially hepatotoxic (liver toxic) level of the pain reliever and fever reducer, acetaminophen.
Hospitals, emergency rooms, clinics, physician offices, and other healthcare facilities and providers are advised to not use the recalled Acetylcysteine Solution lot for patient care. The recalled medication should be immediately quarantined for return.
Patients who may have received the recalled product from this lot are advised to return the recalled medication to their pharmacist. Distributors and retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, which is located at 6101 North 64th Street, Milwaukee, WI 53218. GENCO may be reached, toll-free, at 800-633-1422 for information on the recall process. For technical product information or to report a technical product complaint, call 800-962-8364 (select menu option 5). Adverse reactions or quality problems experienced with the use of this product may be reported to FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
