Hospira announced a voluntary recall of one lot of 50% Magnesium Sulfate Injection, 10g/20mL (0.5g/mL), 20mL single-dose vials. The recall is following a confirmed customer complaint regarding the presence of particulate matter in one single-dose fliptop vial.
The affected product has Lot # 50-343-DK with an expiration date of 2/1/17. It is supplied as 1 box of 25 units per case and 4 boxes of 25 units per case. It was distributed from March 2015 through June 2015. A recall for this lot was previously announced on March 23, 2016 after a confirmed high out of specification (OOS) result for pH.
Magnesium Sulfate Injection is indicated for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those seen in hypocalcemia. The product can also be added to nutrient admixture in total parenteral nutrition (TPN) to correct or prevent hypomagnesemia that may develop during therapy. In addition, it is also used for the prevention and control of seizure in pre-eclampsia and eclampsia.
The patient will likely be unharmed if the particulate is detected prior to dispensing or administration. If therapy is delayed, however, it may lead to potentially serious medical consequences for the mother and fetus requiring medical intervention. If the particulate is not detected prior to administration, localized swelling, redness, injection site pain, allergic reactions, microembolic effects, and possible fetal harm may occur.
For more information call (866) 201-9068 or visit FDA.gov.