359 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 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 Crystallization
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Reason CGMP deviations
Reason CGMP deviations
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Reason Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The…
Reason Failed Dissolution Specifications
Reason Microbial Contamination of Non-Sterile Product
Reason Microbial contamination of non-sterile Products -
Reason Discoloration
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility