  |
Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials
AUDIENCE: Risk Manager, Pharmacy
ISSUE: Fresenius Kabi USA notified health professionals of 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 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.
The administration of glass particulate, if present in a parenteral drug, can lead to sequelae of thromboembolism, some life-threatening (such as pulmonary emboli); phlebitis, mechanical block of the capillaries or arterioles; activation of platelets; and subsequent generation of microthrombi. 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, a protective local inflammatory response to the foreign material.
BACKGROUND: 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.
RECOMMENDATION: All customers who received the recalled vials are being notified and instructed to return any unused product to their supplier.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
