Bedford Laboratories™ Statement Regarding Nationwide Voluntary Recall Of One Lot Of Indomethacin For Injection, USP 1 MG Single Dose Vial

Date of Recall

2011-06-15

Recall Details

- June 13, 2011 - Bedford Laboratories™, a division of Ben Venue Laboratories, Inc., initiated a nationwide voluntary recall of the following product:Indomethacin for Injection, USP, 1mg Single Dose Vial
NDC #55390-299-01, Lot 1948138, Exp. Date September 2011

PLEASE NOTE: This recall is for Lot 1948138 Only. No other lots of Indomethacin for Injection, USP are subject to this voluntary recall.

This voluntary recall was initiated because some of the vials of lot number 1948138 may contain particulate matter. Out-of-specification results were obtained for Lot 1948138 for particulate matter ≥ 10 micron. The product did meet specification for particulate matter ≥ 25 micron. The particulate matter has been identified as active drug substance and not foreign material or contamination. Indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants, who typically have small blood vessels. FDA has stated that particulate matter may provoke an immune reaction and/or lead to microinfarcts which could be serious and life threatening.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use Bedford Laboratories' Indomethacin Injection, USP 1mg Vials, with Lot 1948138, for patient care and should immediately quarantine any product for return.

On April 19, 2011, Bedford Laboratories notified its wholesalers and distributors by email, facsimile and/or overnight courier and arranged for return of all recalled product. Should consumers/distributors/retailers still have product which is being recalled, they should stop use and contact Bedford Laboratories Customer Service.

Bedford Laboratories will credit accounts for all returned product with lot 1948138. Those with questions about the return or recall process, please call our Customer Service Department at 1.800.562.4797: Monday - Friday from 8:00 am to 5:30 pm or by email at [email protected].

Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers, or patients with product quality compliance, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1.800.521.5169.

Any adverse reactions experienced with the use of this product should be reported to Bedford Laboratories at 1.800.521.5169.

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.

As is standard practice, and as stated in the Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."

Indomethacin for Injection, USP is manufactured by Ben Venue Laboratories, Inc. and is distributed by Bedford Laboratories.

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 contract 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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