On March 28, 2016, B. Braun Medical Inc. of Irvine, CA recalled one lot of 5% Dextrose Injection USP 100/150mL in PAB 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. This recall is being conducted with the knowledge of the FDA.
See the Recall
See the FDA Safety Alert
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication