557 recalls, newest first
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason CGMP violations.
Reason CGMP violations.
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Reason Failed Impurities/Degradation Specifications.
Reason Presence of Particulate Matter: Presence of glass particulates.
Reason Defective Container: Firm received complaints of broken tube at the seal.
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason CGMP violations
Reason Crystallization
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Reason Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium…
Reason CGMP deviations