This Medication Is Being Recalled Effective Immediately, FDA Warns
The quality-control issue could result in serious infection.
When a medical manufacturer voluntarily recalls a drug, the probability of adverse effects may be statistically low. Still, when injuries do happen as the result of recalled drugs, they can be serious and even life threatening—so recalls should be taken seriously and acted on immediately. Read on to learn which drug is currently being recalled around the United States and what to do if you think you might have encountered it as a patient.
B. Braun Medical is recalling five lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel in circulation around the U.S.
B. Braun Medical Inc. is voluntarily recalling five lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States. Hospitals and users already have this drug in hand after it was distributed around the country to domestic distributors, according to the recall notice published on the U.S. Food & Drug Administration (FDA) website.
The company announced the recall on Mar. 2 and the FDA published the notice on Mar. 3; this recall is being conducted with the FDA's knowledge. Recalled lots include J1E086, J1E204, J1E213, J1H137, and J1H138, which all have expiration dates in May or June 2022.
The drug has various applications around hydration and blood transfusions.
These intravenous solutions are indicated for use in adults and kids as sources of electrolytes and water for hydration. Specifically, this drug is indicated for "extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss, and mild sodium depletion," according to the recall notice. The 0.9% Sodium Chloride Injection USP in Excel is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells.
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The reason for the recall is leaking or inadequate fluid.
The company initiated the voluntary recall due to fluid leakage or low fill volume within the containers. "The biggest risk with a slow leak in any intravenous solution preparation is a break in sterility, which poses a risk for the patient being exposed to a bacterial or fungal infection," according to the recall notice. And although the probability of it happening is remote, the problem could lead to bloodstream infection. Fortunately, however, B. Braun has not received any reports of adverse events related to this recall at this stage.
Here's what you should do if you might have been given the recalled drug and experienced adverse effects.
The company is notifying its distributors and customers via an official recall notice sent by way of certified registered mail, and is arranging for return of all recalled products. Any facilities and distributors that have product in stock are being asked to discontinue use immediately and contact the B. Braun Medical Inc. customer support department at 800-227-2862 Monday through Friday, 8 a.m. through 6 p.m. EST to arrange for product return.
If you have any questions regarding the recall, contact B. Braun by phone during those same business hours. If you're a patient who think you might have experienced any problems related to using this drug, you're advised to contact your doctor or healthcare provider.
Further, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online. Other reporting options include regular mail or fax, which both start by downloading this reporting form. Complete it and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.