May 23, 2016 — The National Agency for Food and Drug Administration and Control has been notified of the voluntary recall of one lot of 50% Magnesium Sulphate Injection, USP, 10g/20ml (0.5g/ml), 20ml single dose vials by Hospira, Inc., a Pfizer subsidiary company due to the presence of particulate matter. Particulate matter was confirmed to contain high out of specification result for pH in one single dose fliptop vial.
Magnesium sulphate injection is indicated for replacement therapy in magnesium deficiency especially in acute hypomagnesemia. It is also used for the prevention and control of seizures 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 foetus requiring serious medical intervention. If not detected prior to administration, localized swelling, redness, injection site pain, allergic reactions, microembolic effects and possible foetal harm may occur.
Expiration Date: 01/02/2017
Healthcare Provider’s Action
Healthcare providers should discontinue the use and distribution of any existing inventory of the product and quarantine the product
Report all serious adverse events or side effects related to the use of this product to NAFDAC PRASCOR (20543 – Toll free from all network) oor email@example.com