Article
Recall Issued for Dextrose Injection
Author(s):
Voluntary recall for1 lot of 5% dextrose injection USP 100/150 mL container due to potential leakage and microbial growth.
B. Braun Medical Inc has initiated a voluntary recall of 1 lot of 5% dextrose injection USP 100/150 mL container due to potential leakage and microbial growth.
Lot #J5J706, catalog #S5104-5264, NDC 0264-1510-32, is affected by the recall. This product is packaged in B. Braun’s Partial Additive Bag with 64 units per case. The lot expires October 31, 2016, and was distributed to pharmacies, hospitals, and licensed distributors.
Thus far, the issues with the injection were discovered before it was administered, and B. Braun Medical Inc has not heard of any reports of adverse effects.
Leakage could cause contamination of the solution, which could lead to microbial contamination, and administration of such a product may result in potentially life-threatening infections.
B. Braun Medical is notifying all of its distributors and customers of the recall. Individuals who have products from the impacted lot in their possession are advised to discontinue use immediately and arrange for a replacement.
The FDA advised that all adverse reactions or quality problems related to the product should be reported to B. Braun’s Clinical and Technical Support Department. Adverse reactions should also be reported to the FDA’s MedWatch Adverse Event Reporting Program online or via mail.
