Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
FDA Drug Recalls
1,464 recalls · Class II, newest first
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 2:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class II · Moderate risk
Clarithromycin Tablets
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
Captopril Tablets
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
CONTRAVE (naltrexone HCl and bupropion HCl)
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
SUCRETS Sore Throat & Cough Vapor Cherry lozenges
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
Mycophenolic Acid Delayed-release Tablets
Failed Dissolution Specifications: Low out of specification dissolution results.
Class II · Moderate risk
Estradiol Cypionate
Lack of Assurance of Sterility
Class II · Moderate risk
DMSO (Sterile Water)
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Tetradecyl Sulfate
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Tetradecyl
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Hyaluronate
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Hyaluronate
Lack of Assurance of Sterility