Class II · Moderate risk Ongoing
TIRZEPATIDE 60 mg/3mL
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Ongoing
TIRZEPATIDE 20 mg/2mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
SEMAGLUTIDE 10mg/4mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
SEMAGLUTIDE 5mg/2mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide 2 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefixime for Oral Suspension USP
Reason Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class III · Low risk Terminated
Just Right 5000
Reason LABELING: LABEL MIX-UP.
Class II · Moderate risk Ongoing
Lidocaine HCl Injection
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Varithena
Reason Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Ibuprofen 800mg
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II · Moderate risk Ongoing
Ibuprofen Tablets
Reason Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II · Moderate risk Ongoing
Testosterone Gel
Reason Superpotent Drug
Class III · Low risk Completed
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk Completed
Hand-I-San
Reason CGMP Deviations: sterile water not used for production
Class II · Moderate risk Completed
Rubbing Alcohol
Reason CGMP Deviations: sterile water not used for production
Class II · Moderate risk Terminated
Empower Pharmacy
Reason Lack of Assurance of Sterility
Class I · High risk Ongoing
Heparin
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class III · Low risk Completed
Methotrexate Tablets
Reason Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules
Reason Failed Dissolution Specifications: below specification results