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Lack of Assurance of Sterility: Leaking vials
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Discoloration: Brownish tablets
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Failed Impurities/Degradation Specifications.
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.
Lack of Assurance of Sterility: Complaints of syringe breakage
Lack of Assurance of Sterility
Lack of Assurance of Sterility.