Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord…
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 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 Specifications
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 Stability Specifications
Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of…
Reason Defective Delivery System
Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Reason Packaging defect: blister packaging inadequately sealed.
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
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