Class II · Moderate risk
Diclofenac Sodium Topical Solution 1.5% w/w
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
Econazole Nitrate Cream
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Clobetasol Propionate Lotion 0.05%
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk
Testosterone Cypionate *gs*
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
Testosterone Cypionate/ Anastrozole *gs* Oil
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
(ca) Gonadorelin
Lack of sterility assurance.
Class II · Moderate risk
Gonadorelin
Lack of sterility assurance.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril HCl/hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril HCl/hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril and hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Orphenadrine Citrate Extended-Release Tablets
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Class II · Moderate risk
The Natural Dentist Healthy Breath Antiseptic Rinse
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 II · Moderate risk
Glycopyrrolate Tablets
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
Enalapril Maleate Tablets
CGMP Deviations