Class III · Low risk Terminated
Dexamethasone Elixir
Reason Failed Impurities/ Degradation Specifications
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Albuterol Sulfate Inhalation Solution
Reason Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk Terminated
Montelukast sodium tablets
Reason Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Class III · Low risk Terminated
Dye Free Allergy Softgel Gelatin Capsule
Reason Subpotent
Class III · Low risk Terminated
Diphenhydramine HCl 25 mg
Reason Subpotent
Class III · Low risk Terminated
Donepezil HCl tablets
Reason Supotent: Out of Specification result for assay test during routine stability testing.
Class III · Low risk Terminated
Finasteride Tablets
Reason Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Class III · Low risk Terminated
Aripiprazole Tablets
Reason Superpotent Drug; out of specification results for assay (manufacturer)
Class III · Low risk Terminated
Temazepam Capsules USP
Reason Failed Stability Specifications
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-release Tablets
Reason Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-release Tablets
Reason Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk Terminated
Aripiprazole Tablets
Reason Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk Terminated
Pantoprazole Sodium for Injection
Reason Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Class III · Low risk Terminated
Azelastine Hydrochloride Nasal Solution
Reason Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Class III · Low risk Terminated
Donepezil Hydrochloride Tablets
Reason Subpotent Drug: out of specification results for assay test.
Class III · Low risk Terminated
VirtPrex Prenatal/Postnatal Tablets
Reason cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk Terminated
Virt-Select Prenatal/Postnatal Softgels
Reason cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk Terminated
Extra-Virt Plus DHA Prenatal/Postnatal Softgel
Reason cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk Terminated
Virt-Advance Prenatal/Postnatal Softgels
Reason cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk Terminated
Novacort Gel Sample Packets
Reason Subpotent Drug: Out of specification result for pramoxine hydrochloride
Class III · Low risk Ongoing
Inova
Reason Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Class III · Low risk Terminated
Endure 400 Scrub-Stat
Reason Subpotent Drug
Class III · Low risk Terminated
Pentasa
Reason Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Class III · Low risk Terminated
Risedronate Sodium Delayed-release Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Protonix I.V.
Reason Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.