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377 recalls · newest first
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CGMP Deviations
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA…
Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.