Class II · Moderate risk Ongoing
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
Reason Subpotent Drug
FDA Drug Recalls
411 recalls · Class II, newest first
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 Ongoing
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per…
Reason Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II · Moderate risk Ongoing
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for…
Reason Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of…
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 Ongoing
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort…
Reason Failed Dissolution Specifications
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 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
Class II · Moderate risk Completed
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA…
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.