MANILA, Philippines—A pharmaceutical company has voluntarily recalled a batch of vaccines for Hepatitis A due to quality issue, according to the Food and Drug Administration (FDA).
In an advisory, the FDA said Vizcarra Pharmaceutical Inc. was voluntarily recalling a batch of Hepatitis A vaccine (inactivated, virosome) 24 IU/0.5 mL solution for IM injection.
The impacted lot has the brand name Epaxal and registration number BR-426.
According to FDA officer-in-charge Nicolas Lutero III, the recall stemmed from a “quality issue identified at the product manufacturer, Crucell Switzerland AG, manufacturing facility in Spain.”
He cited reports that “traces of iron oxide particles were confirmed being released from the stopper feeding station on the filling lines.”
“The affected product lots present safety risk and potential adverse health consequences,” the FDA said.
The affected lot numbers are 3000060.08, 3000144.03, 3000144.06, 3000502.02, 3000734.02, and 3000734.04.
The vaccine is used for immunization against Hepatitis A from beginning one year of age. The product is packed in a 0.5mL prefilled glass syringe per box with a needle.
The FDA instructed distributors, retailers, hospitals, pharmacies or clinics with the affected lots to discontinue further distribution, sale and use.
Consumers were also advised not to buy or use the affected products, while FDA regulation officers have instructions to monitor the vaccines in the market.
Vizcarra Pharmaceutical may be contacted at 5245641, while the FDA may be contacted at info@fda.gov.ph for questions or additional information regarding the recall.
Adverse reactions from the use of the recalled products may be reported to the FDA.