ISSUE: B. Braun Medical Inc. is 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.
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.
BACKGROUND: 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.
RECOMMENDATION: 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.
Click here to read the MedWatch safety alert, including a link to the press release.