Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Reason Superpotent Drug: Stability failure for assay at 6 months test time-point.
17,898 recalls, newest first
Reason Superpotent Drug: Stability failure for assay at 6 months test time-point.
Reason Labeling: Label Mix-Up
Reason Labeling: Label Mix-Up
Reason Subpotent Drug
Reason CGMP Deviations
Reason Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability…
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine 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 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