💊 Drugs • 12,141 recalls
Teva Pharmaceuticals USA
Failed Dissolution Specifications
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Failed Dissolution Specifications
Presence of Particulate Matter: Due to production issues
Teva Pharmaceuticals USA
Failed Dissolution Specifications
Teva Pharmaceuticals USA
Failed Dissolution Specifications
Teva Pharmaceuticals USA
Failed Dissolution Specifications
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Fresenius Kabi Compounding
Lack of Assurance of Sterility
Fresenius Kabi Compounding
Lack of Assurance of Sterility
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Fresenius Kabi Compounding
Lack of Assurance of Sterility
Fresenius Kabi Compounding
Lack of Assurance of Sterility
Tablets/Capsules Imprinted with Wrong ID