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Ben Venue Labs Recalls Inhalation Medication Over Glass Particles

Feb 19, 2014

Ben Venue Laboratories, Inc. just issued a recall of one lot of Acetylcysteine Solution 10%, Usp, which was manufactured for Roxane Laboratories, Inc. A visible glass particle was discovered in a vial in this lot of inhalation medication.

Acetylcysteine is typically used with a Nebulizer, but may also be used with direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchoscopy, the U.S. Food and Drug Administration (FDA) announced. The medication is packaged in a 30 mL vial and bears NDC #0054-3025-02, Lot 2005479, and Exp. Date March 2014.

Should glass particles enter the body during treatment, airway obstruction may occur and may lead to choking; wheezing; difficulty breathing; coughing; and potentially, hemoptysis (expectoration of blood). When an inhaled product with glass particles is used, choking, which may be life-threatening, may occur. Aerosolization of small glass particles in the airways may also lead to recurrent infections because of airway obstruction and decreased clearance of airway secretions.

Acetylcysteine is approved as adjuvant therapy for patients who are diagnosed with abnormal, viscid, or inspissated (very thick) mucous secretion. Acetylcysteine, which is administered orally, is also approved as an antidote to prevent or minimize hepatic (liver) injury, which may occur following ingestion of a potentially hepatotoxic quantity of acetaminophen.

Hospitals, emergency rooms, clinics, physician offices, and other healthcare facilities and providers are advised against using the recalled Acetylcysteine Solution lot for patient care. The medication should immediately be quarantined for return.

Patients who may have received the recalled product from this lot should return the product to their pharmacist. Distributors/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 and select menu option 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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