Hep-A Vaccine Recalled by FDA

Hep-A Vaccine RecalledAccording to the FDA, Vizcarra Pharmaceutical has voluntarily recalled a batch of vaccines for Hepatitis A due to quality issues found in the product manufacturer, Crucell Switzerland AG manufacturing facility in Spain.

The FDA issued an advisory informing the public that the affected product presents safety risks and potential adverse reactions. Distributors, retailers, hospitals pharmacies, or clinics that have the affected lots are instructed to discontinue further distribution sale and use of the hep-a vaccine. Consumers are also advised not to buy or use the affected products.

Hep-A Vaccine and The Quality Issues

Hepatitis A vaccines are recommended for:

  • All children at age 1 year
  • Travelers to countries that have high rates of Hepatitis A
  • Men who have sexual contact with other men
  • Users of injection and non-injection illegal drugs
  • People with chronic live diseases such as Hepatitis B or C

However, since the FDA cited reports that traces of iron oxide particles were confirmed being released from the stopper feeding stations on the filling lines consumers are advised not to buy or used the affected products.

The affected lot numbers are:

  • 3000060.08
  • 3000144.03
  • 3000144.06
  • 3000502.02
  • 3000734.02
  • 3000734.04

The FDA may be contacted at info@fda.gov.ph for questions or additional information regarding the recall.


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