Class III · Low risk Terminated
Buprenorphine and Naloxone Sublingual Tablets
Reason Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Obagi-C Rx System C-Therapy Night Cream
Reason Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
Class II · Moderate risk Terminated
parodontax WHITENING
Reason Presence of Foreign Substance: possibility of the presence of metal in the product.
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in…
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in…
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Timolol-Brimonidine-Dorzolamide-Latanoprost
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Timolol-Latanoprost PF Solution
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Latanoprost PF Solution
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Curcumin Emulsion 10mg/ml Injection
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class III · Low risk Terminated
Paroxetine Extended-Release Tablets USP
Reason Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Class II · Moderate risk Terminated
Potassium Phosphate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Potassium Phosphate
Reason Lack of Assurance of Sterility