Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets
Reason Failed Dissolution Specifications
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Blephamide
Reason Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class II · Moderate risk Terminated
Buprenorphine HCI Injection
Reason Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Class II · Moderate risk Terminated
Clozapine Tablets USP
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Phenobarbital Tablets USP
Reason Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk Terminated
Amitriptyline HCL Tablets
Reason Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk Terminated
Phenobarbital Tablets USP
Reason Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk Terminated
Phenobarbital Tablets USP
Reason Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk Terminated
Estradiol 6 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 10 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 12.5 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 15 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 18 mg pellet
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 20 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 22 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 25 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Shield and Protect Moisture Barrier Cream
Reason GMP Deviations; product may not meet cGMP requirements
Class II · Moderate risk Terminated
Vitamin D3 in Olive Oil Sdv 100
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
Vitamin D3 in Olive Oil Sdv 100
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
Vitamin B Complex 1ml Sdv Na Inj
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
Testost Aq Mdv 50mg/Ml Inj
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
Testost Cyp Sesame Oil 5ml Mdv 100mg/Ml Inj
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated
Sod Phenylbutyrate Sdv 30ml
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.