Class II · Moderate risk Ongoing
Oxacillin for Injection
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Ongoing
Fingolimod Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk Terminated
ROcuronium Bromide 50 mg/5 mL
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk Terminated
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk Terminated
SUCCINYLcholine Chloride 200 mg/10mL
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk Ongoing
Big Machine Distillery Hand Sanitizer Non-Sterile Solution…
Reason CGMP Deviation: impurities exceed allowable limits.
Class II · Moderate risk Terminated
Tiagabine Hydrochloride Tablets
Reason Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class II · Moderate risk Terminated
Norepinephrine 32 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 16 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 8 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 4 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Loteprednol Etabonate Ophthalmic Suspension
Reason Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of assurance of sterility: bags have the potential to leak.
Class II · Moderate risk Terminated
Sunitinib Malate Capsules
Reason Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Class II · Moderate risk Terminated
Bivalirudin for Injection 250 mg
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk Terminated
Atropine Sulfate Injection
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class I · High risk Terminated
Albuterol Sulfate Inhalation Aerosol
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class III · Low risk Terminated
Amlodipine Besylate Tablets
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class II · Moderate risk Ongoing
Tizanidine Hydrochloride Tablet 4mg
Reason Failed Stability Specifications
Class I · High risk Terminated
Tydemy
Reason Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Class II · Moderate risk Terminated
Safe Tussin PM Night Time Cough Relief
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Terminated
Safe Tussin DM Cough + Chest Congestion
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.