Leiters Health, a pharmaceutical company, has initiated a voluntary nationwide recall of specific lots of its intravenous (IV) drug products. As of January 5, 2024, the company has recalled 33 lots of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags. This recall is due to concerns over the products potentially containing a superpotent dosage, meaning they may contain double the labeled amount of the drug. This was discovered following an issue with the semi-automated IV bag filling equipment used by Leiters Health, which malfunctioned when compressed air tanks were low or a leak was detected, resulting in some IV bags being filled with twice the intended dose.
The recalled products include various lots of vancomycin, phenylephrine, and fentanyl, each with specific lot numbers and expiration dates. These products, identified by item numbers F3355, F3342, F3360, F3352, F3206, and F3208, come in different concentrations and have been distributed in various sizes of IV bags. The risk associated with these superpotent drugs is significant, as they could lead to life-threatening adverse events. For instance, administering vancomycin at double the infusion rate can cause serious complications like low blood pressure, shock, cardiac arrest, respiratory issues, skin reactions, acute kidney injury, and ototoxicity. Similarly, administering a higher dose of fentanyl than intended can result in profound respiratory depression, hypoxia, and potentially fatal cardiac events. Overdosing on phenylephrine could also lead to dangerously high blood pressures in patients.
To date, Leiters Health has not reported any adverse events related to this recall. The products in question were distributed to hospitals across the nation for administration to patients in hospital settings. In response to the recall, Leiters Health has informed its customers through mailed letters and emails. The company is also providing credit for all recalled products and has instructed customers to cease using the affected products immediately.
Consumers and healthcare providers with questions regarding this recall can reach out to Leiters Health at 1-800-292-6772 or via email at recall@leiters.com. They are advised to report any adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program.
The potential harm caused by these superpotent IV drugs is a serious concern, and individuals who have suffered injuries or adverse health effects due to this issue may consider seeking legal action. Filing a product liability lawsuit in such cases involves proving that the product was inherently dangerous due to its defective nature or manufacturing error. Victims would need to navigate a complex legal process, which includes collecting evidence, filing the lawsuit, negotiating with the responsible parties, and possibly going to trial.
Having a knowledgeable attorney is crucial in such cases, as they can guide victims through each stage of the lawsuit and ensure their rights are protected. Successful product liability claims can result in compensation for medical expenses, pain and suffering, lost wages, and in some cases, punitive damages.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
For individuals affected by the recalled Leiters Health IV products, legal support is available through Parker Waichman LLP. The firm offers free consultations to victims, providing guidance and representation in pursuing compensation for injuries and damages. Those affected can contact Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529) to explore their legal options.
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.
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