Class II · Moderate risk Terminated
Testosterone Cypionate *gs*
Reason Lack of sterility assurance.
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Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Testosterone Cypionate/ Anastrozole *gs* Oil
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
(ca) Gonadorelin
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Gonadorelin
Reason Lack of sterility assurance.
Class I · High risk Terminated
Symjepi
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class I · High risk Terminated
Symjepi
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
quinapril HCl/hydrochlorothiazide tablets
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
quinapril HCl/hydrochlorothiazide tablets
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
quinapril and hydrochlorothiazide tablets
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Orphenadrine Citrate Extended-Release Tablets
Reason CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Class II · Moderate risk Terminated
The Natural Dentist Healthy Breath Antiseptic Rinse
Reason Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
Class III · Low risk Terminated
Netspot
Reason Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class II · Moderate risk Terminated
Glycopyrrolate Tablets
Reason Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations