Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703…
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
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Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Reason Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Reason Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and…
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of…
Reason Packaging defect: blister packaging inadequately sealed.
Reason cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Labeling: Label Mix-up
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and…