A pharmaceutical company is voluntarily recalling a batch of hepatitis A vaccines because of a quality issue. A Food and Drug Administration Philippines advisory listed six lots of the vaccine, with the brand name Epaxal, that are affected by this recall.
The vaccines were manufactured in Spain by Crucell Switzerland AG and shipped to the Philippines. The FDA Philippines advisory indicates, “traces of iron oxide particles were confirmed being released from the stopper feeding station on the filling lines.”
The agency said affected vaccines “present safety risk and potential adverse health consequences.” Distributors, hospitals, doctor’s offices and pharmacies are instructed to discontinue distribution, sale and use of the lots in the recall.
The affected lot numbers are 3000060.08, 3000144.03, 3000144.06, 3000502.02, 3000734.02, and 3000734.04 of 24IU/0.5 mL solution for IM injection. FDA Philippines regulation officers are monitoring to see if these lots have made it into the market.