Class II · Moderate risk Terminated
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Reason CGMP Deviations
FDA Drug Recalls
161 recalls, newest first
Class II · Moderate risk Terminated
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
Reason CGMP Deviations
Class II · Moderate risk Terminated
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…
Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II · Moderate risk Terminated
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging…
Reason Failed Impurities/Degradation Specification.
Class II · Moderate risk Terminated
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and…
Reason Lack of Sterility Assurance: Aseptic process simulation failure.
Class II · Moderate risk Terminated
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class I · High risk Terminated
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC…
Reason Labeling: Label Mix-up
Class II · Moderate risk Terminated
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark…
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk Terminated
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…
Reason Failed Impurities/Degradation Specifications