B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Lot J5J706, 5% Dextrose Injection USP in PAB Container Due to Leakage and/or Particulate Matter Identified To Be Microbial Growth
- Company Announcement Date:
- March 28, 2016
- FDA Publish Date:
- December 01, 2018
- Product Type:
- Reason for Announcement:
- Company Name:
- B. Braun Medical Inc.
- Brand Name:
Brand Name(s)B. Braun Medical Inc.
- Product Description:
Product Description5% Dextrose Injection USP
B. Braun Medical Inc. of Irvine, CA is voluntarily recalling one lot of 5% Dextrose Injection USP 100/150mL container (Lot #J5J706, catalog #S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be microbial growth. To date all failures have been identified before the use of the product and there have been no reports of adverse events associated with this issue.
A compromise of container integrity has the potential for leakage of the solution, usually identified prior to the use of the product. Leaking containers allow contamination of the solution, which can and has led to microbial contamination. Intravenous administration of a non-sterile product can result in serious infections that may be life-threatening.
This product is intended for intravenous administration and may be used as a diluent and delivery system for intermittent administration of compatible drug additives. The product is packaged in B. Braun's PAB® (Partial Additive Bag) container with 64 units per case. The affected lot J5J706, which expires 10/31/2016, was distributed nationwide to licensed distributors, hospitals, and pharmacies.
B. Braun is notifying its distributors and customers by certified mail and is arranging for the return of all recalled product. Distributors and customers that have inventory of lot J5J706, 5% Dextrose Injection USP 100/150mL container, should discontinue use immediately and contact B. Braun Medical Inc.'s Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST) for instructions for returning the affected product and to arrange for replacement product.
Consumers with questions regarding this recall can contact B. Braun Medical Inc.'s Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product should be reported to B. Braun's Clinical and Technical Support Department at 1-800-854-6851. Additionally, any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is part of the B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, Pa., and includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 54,000 employees in more than 60 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
ConsumersB. Braun Medical Inc.
Customer Support Department