Class III · Low risk
Finasteride Tablets
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
FDA Drug Recalls
159 recalls · Class III, newest first
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
Class III · Low risk
Temazepam Capsules USP
Failed Stability Specifications
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk
Pantoprazole Sodium for Injection
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Class III · Low risk
Azelastine Hydrochloride Nasal Solution
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
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
Class III · Low risk
VirtPrex Prenatal/Postnatal Tablets
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Virt-Select Prenatal/Postnatal Softgels
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Extra-Virt Plus DHA Prenatal/Postnatal Softgel
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Virt-Advance Prenatal/Postnatal Softgels
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Novacort Gel Sample Packets
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Class III · Low risk
Endure 400 Scrub-Stat
Subpotent Drug
Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Class III · Low risk
Risedronate Sodium Delayed-release Tablets
Failed Dissolution Specifications
Class III · Low risk
Protonix I.V.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Class III · Low risk
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick
Labeling: Label Mix Up- Incorrect back label applied to the product.
Class III · Low risk
Sodium Ferric Gluconate Complex in Sucrose Injection
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class III · Low risk
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation
Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Class III · Low risk
Amoxicillin for Oral suspension
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Class III · Low risk
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications: OOS results for known compound.
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 6 month time point
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.