Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
morphine sulfate in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
morphine sulfate in 0.9% Sodium Chloride injectable
Reason Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk Terminated
Nystatin Topical Powder
Reason Presence of Foreign Substance: potential presence of plastic particles.
Class II · Moderate risk Ongoing
Ventolin HFA
Reason Defective Delivery System: Elevated number of units with out of specification results for leak rate
Class II · Moderate risk Terminated
Milrinone Lactate in 5% Dextrose Injection
Reason Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk Terminated
Oxygen Refrigerated Liquid USP UN 1073
Reason GMP Deviations: The firm does not include an SOP for testing for out of specifications.
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
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