Class II · Moderate risk Ongoing
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL
Reason Lack of Assurance of Sterility
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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 Ongoing
Lidocaine HCl Injection
Reason Lack of Assurance of Sterility
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 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 I · High risk Ongoing
Heparin
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules
Reason Failed Dissolution Specifications: below specification results
Class II · Moderate risk Ongoing
Progesterone Injection
Reason Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class I · High risk Ongoing
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Ciprofloxacin ophthalmic solution USP
Reason Defective container: 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
Glenmark
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective container; yellow colored spike from cap lodged in the nozzle
Class I · High risk Ongoing
Umary Acido Hialuronico
Reason Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk Ongoing
Umary Acido Hialuronico
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk Ongoing
Gold Hard Steel Plus Liquid
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk Ongoing
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk Ongoing
Healthy Living Acetaminophen
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.