Drug Safety Alerts

5% Dextrose Injection USP 100/150mL Consumer-Level Recall

3/29/2016


On March 29, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall on 5% dextrose Injection 100/150mL containers NDC # 00264-1510-32 manufactured by B. Braun Medical Inc. This recall was issued due to an adverse quality trend in customer complaints reporting that some containers 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.

This recall affects lot number J5J706 exp. 10/31/16. No other lots are affected by this recall.

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 was distributed nationwide to licensed distributors, hospitals, and pharmacies.

CVS/caremark Response:

Please note: This product is not carried by the CVS/caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact B. Braun Medical Inc’s Customer Support Department at 1-800-227-2862, Monday through Friday, 8:00 a.m. to 6:00 p.m. (EST). You may also call the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888‑463‑6332) or visit https://www.fda.gov/Safety.