Class II · Moderate risk Terminated
Tpn 3:1
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Tpn 3:1
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Tpn 3:1
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Tpn 3:1
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Tpn 3:1
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Tpn 3:1
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets
Reason Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets
Reason Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class II · Moderate risk Terminated
Clarithromycin Tablets
Reason cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Class II · Moderate risk Terminated
Captopril Tablets
Reason cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Class II · Moderate risk Terminated
Contrave
Reason Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Class II · Moderate risk Terminated
SUCRETS Sore Throat & Cough Vapor Cherry lozenges
Reason Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.
Class II · Moderate risk Terminated
Mycophenolic Acid Delayed-release Tablets
Reason Failed Dissolution Specifications: Low out of specification dissolution results.
Class II · Moderate risk Terminated
Estradiol Cypionate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dmso
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vitamin D3
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Tetradecyl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Hyaluronate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Hyaluronate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Nanpyridoxine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Nandrolone Decanoate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate
Reason Lack of Assurance of Sterility