358 recalls · Class II, newest first
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP deviation: product released prior to supplier approval.
Reason Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of…
Reason Mislabeling: preservative free product labeled as preserved.
Reason Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Reason Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a…
Reason Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the…
Reason Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the…
Reason Lack of assurance of sterility: Bags have the potential to leak.
Reason Failed impurities/degradation specifications: Out of specification for unknown impurities.
Reason CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Reason Out of specification for related substances (impurities).
Reason Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.