Recall -- Firm Press Release
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Fresenius Kabi USA Initiates Voluntary Recall of Single Lot of Magnesium Sulfate
FOR IMMEDIATE RELEASE - May 25, 2013 - Fresenius Kabi USA announced today it has initiated a voluntary recall of one lot – Lot 6103882 – of Magnesium Sulfate Injection, USP due to the potential presence of glass particles in the vials. The recall is a precautionary measure, following a routine company inspection of retained product samples.
No adverse events, patient reactions or customer complaints have been reported to date. All customers who received the recalled vials are being notified and instructed to return any unused product to their supplier.
The recalled product is labeled with Product Code 6450 and packaged as 500mg/mL strength in 50mL glass vials (25 vials per tray). The product was shipped in the United States between May 30, 2012 and June 6, 2012 and has an expiration date of October 31, 2014.
Magnesium sulfate is used as electrolyte replacement therapy in the treatment of magnesium deficiency, and as an anticonvulsant to prevent and control seizures in severe toxemia of pregnancy.
The administration of glass particulate, if present in a parenteral drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically nonserious. The defect discovered in this product lot was noted as visible particulate.
To report adverse events or quality problems experienced with the use of this product, call Fresenius Kabi USA’s Vigilance and Medical Affairs at 1-800-551-7176, Monday through Friday, between the hours of 8 a.m. and 5 p.m. (CST), or by e-mail appmedicalinfo@APPpharma.com.
Adverse events may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Online: www.fda.gov/medwatch/report.htm.
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178
Additional Fresenius Kabi contact information
Health care professionals can find additional information about the recall on the company’s web site (www.apppharma.com/our-products/productupdates) or by calling Fresenius Kabi USA Quality Assurance at 1-866- 716-2459, Monday through Friday, between the hours of 8 a.m. and 5 p.m. (CST).
Questions regarding product availability and ordering can be directed to Fresenius Kabi USA Customer Service at 1-888-386-1300, Monday through Friday, between the hours of 7 a.m. and 6 p.m. (CST).
Fresenius Kabi USA is the U.S. subsidiary of Fresenius Kabi, a global health care company that focuses on medicines and medical devices used to care for critically and chronically ill patients inside and outside the hospital.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com) is a leading global health care company that focuses on medicines and medical devices used to care for critically and chronically ill patients inside and outside the hospital. The company’s products include intravenous specialty and generic medicines, infusion therapies, clinical nutrition, and blood-transfusion technologies. Its roots go back more than 100 years to the founding of our parent company, Fresenius SE, in Bad Homburg, Germany, where the company is headquartered today.