Offering the sale of unapproved influenza vaccine Fluzalp Quadrivalent has landed Davati Medical Supply with a US FDA warning letter.

Fluzalp Quadrivalent is an intramuscular vaccine manufactured by Indian firm Anzalp Pharmasolutions. While Anzalp’s motto is ‘Healthcare with Ethics,’ the same cannot be said for US distributor Davati Medical, which received a US Food and Drug Administration (FDA) warning letter last month for offering the vaccine to US consumers, despite it not being approved in the region.

The company claims on its website that the vaccine “is approved for use in persons 4 years of age and older,” and that each manufactured batch of the vaccine is “tested by FDA for Quantity, Quality and Efficacy before being release into the market.”

Image: iStock/Manjurul

The FDA says these claims, among others, are false.

“Based on our review, this product is an unapproved new drug under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355,” the letter states. “Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).”

The FDA adds the product is also an unlicensed biological. As such the Agency has requested Davati Medical to take immediate action to cease the sale of the vaccine.

“You should take immediate action to correct any violations of the FD&C Act, the PHS Act, and FDA’s implementing regulations,” the FDA says.

“We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product as safe and effective for an Influenza Virus-related use for which it has not been licensed by FDA and that you do not make claims that misbrand the product in violation of the FD&C Act.”

Davati Medical did not respond when contacted by this publication.