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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
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
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Failed Impurities/Degradation Specification
Failed Impurities/Degradation Specification
Labeling: Label Mix-Up
Labeling: Label Mix-Up
Subpotent Drug
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Failed Impurities/Degradation Specifications.
Defective Container: Firm received complaints of broken tube at the seal.
Crystallization
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.