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The company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.
Hospira announced on April 13, 2016 that it was voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10 g/20 mL in single-dose vials due to a customer complaint of the presence of particulate matter found in one single-dose fliptop vial. A press release from the company states that the affected lot, Lot 50-343-DK, Expiration 01FEB2017, NDC 0409-2168-02, was previously recalled on March 23, 2016 due to an out-of-specification result for pH.
The company states that they have not received any adverse event reports associated with the lot, and patient harm is unlikely if the particulate is detected before being administered. However, if not observed prior to administration, the particulate “may result in localized swelling, redness, pain at the site of administration or veins, allergic reactions to the foreign particle, microembolic effects as well as possible fetal harm. The likelihood of serious patient harm is considered low due to high-detectability of this non-conformance.”
Magnesium Sulfate Injection, USP, according to Hospira, is used as a replacement therapy in magnesium deficiency, especially in acute hypomagnesemia. It is also used for the prevention and control of seizure in pre-eclampsia and eclampsia.
Hospira is advising customers to stop use and distribution of any existing inventory and quarantine the product. Adverse events may be reported to FDA’s MedWatch Adverse Event Reporting program.