Prescription and over-the-counter medications
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Zydus Pharmaceuticals (USA)
Failed Impurities/Degradation Specifications.
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Bryant Ranch Prepack
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Lack of Assurance of Sterility: Complaints of syringe breakage
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lack of Assurance of Sterility
Defective container: lack of seal integrity.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Rubicon Research Private Limited
Presence of Foreign Substance: metal in tablet
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate