FDA Drug Recalls
1,803 recalls · Class II, newest first
Jun 7, 2013
Class II · Moderate risk
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Jun 6, 2013
Class II · Moderate risk
Defective container: products are packaged in pouches which may not have been fully sealed
Jun 6, 2013
Class II · Moderate risk
Defective container: products are packaged in pouches which may not have been fully sealed
Jun 6, 2013
Class II · Moderate risk
Defective container: products are packaged in pouches which may not have been fully sealed
Jun 6, 2013
Class II · Moderate risk
Defective container: products are packaged in pouches which may not have been fully sealed
Jun 6, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Jun 4, 2013
Class II · Moderate risk
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Jun 4, 2013
Class II · Moderate risk
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
May 30, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
May 29, 2013
Class II · Moderate risk
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes