557 recalls, newest first
Reason Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone…
Reason Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Reason Failed Impurities/Degradation Specifications - at 18-month Stability testing
Reason Superpotent Drug
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established…
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Reason CGMP Deviations: sterile water not used for production
Reason CGMP Deviations: sterile water not used for production
Reason Lack of Assurance of Sterility
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Reason Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Reason Failed Dissolution Specifications: below specification results
Reason Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Reason Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Reason Presence of Particulate Matter
Reason Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason CGMP Deviations
Reason Defective container; yellow colored spike from cap lodged in the nozzle
Reason Label mix-up: Carton incorrectly labeled.
Reason Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.