Bedford Laboratories Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution, USP, LOT 1877093

Date of Recall

2012-02-02

Recall Details

- February 2, 2012 - BEDFORD, OH - February 2, 2012, Bedford Laboratories™, today issues updated guidance on the following nationwide voluntary product recall originally initiated on December 20, 2011:Acetylcysteine Solution, USP, (Manufactured for Roxane Laboratories, Inc.) 20%, 30 mL per vial - NDC #0054-3026-02 - Lot 1877093 - Exp. Date June 2013

This voluntary recall was initiated on December 20, 2011 after the discovery of a single visible glass particle in a vial within the lot listed above. There have been no complaints or adverse events related to a piece of glass in vials of this lot. All other product parameters were within specifications.

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. Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased clearance of airway secretions).

Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

The key component of this update is the extension of the recall to the patient level. This recall is limited to the one lot number listed above.

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.

For information regarding the recall process, call GENCO Pharmaceutical Services at 800-950-5479 and select menu option 1. For technical product information or to report a technical product complaint, call 800-962-8364 and select menu option 6.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1.800.FDA.0178

Bedford Laboratories has informed the FDA of its actions and is maintaining ongoing discussion with the agency. This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Bedford Laboratories

Bedford Laboratories is located in Bedford, OH and began in 1993 as a division of Ben Venue Laboratories. Bedford Laboratories supplies an extensive selection of critical-care and medically necessary multisource and specialty injectable products to the healthcare marketplace. For more information, please visit http://www.BedfordLabs.com .

About Ben Venue Laboratories, Inc.

Ben Venue Laboratories, Inc. was founded in 1938 and is a leading manufacturer of highly complex, sterile injectable drug products for the global pharmaceutical industry. Ben Venue is located in Bedford, Ohio and employs more than 1,300 people. For more information, visit www.benvenue.com .

Ben Venue is a U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies. Please visit http://us.boehringer-ingelheim.com .

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