Class II · Moderate risk Terminated
Nystatin Topical Powder
Reason Presence of Foreign Substance: potential presence of plastic particles.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class I · High risk Terminated
Mibelas 24 Fe
Reason Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
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 III · Low risk Terminated
Montelukast Sodium Oral Granules
Reason Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Class III · Low risk Terminated
Benzonatate capsules
Reason Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Class III · Low risk Terminated
Hydrocortisone Lotion
Reason Superpotent Drug: above specification for the assay.
Class III · Low risk Terminated
Amlodipine Besylate Tablet
Reason PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Class I · High risk Terminated
GEC LX Laxoplex 60 capsules Dietary Supplement
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
Class III · Low risk Terminated
Famotidine for Oral Suspension USP
Reason CGMP Deviations
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 III · Low risk Terminated
Minivelle
Reason Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Class III · Low risk Terminated
Acyclovir Tablets
Reason Presence of Foreign Substance: human hair melded into tablet.
Class III · Low risk Terminated
Amoxicillin and Clavulanate Potassium Tablets
Reason Subpotent Drug; Clavulanic Acid
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