Class II · Moderate risk
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM
Lack of Processing Control
FDA Drug Recalls
1,356 recalls, newest first
Class II · Moderate risk
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube
Lack of Processing Control
Class II · Moderate risk
Fluorouracil
Lack of Processing Control
Class II · Moderate risk
Testosterone W/Cosmetic HRT Base 100 MG
Lack of Processing Control
Class II · Moderate risk
Estriol Vaginal Cream
Lack of Processing Control
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk
Sunstar GUM Toothpaste 3 g tubes
cGMP Deviation
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Vancomycin 900MG in 100ML 0.9% NACL Injectable
Lack Of Processing Controls
Class II · Moderate risk
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Lack Of Processing Controls
Class II · Moderate risk
Daptomycin
Lack Of Processing Controls
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Acetylcysteine Ophthalmic 10% Solution
Lack Of Processing Controls
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Ethacrynate Sodium for Injection
cGMP Deviations
Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
Olmesartan Medoxomil Tablets 20 mg
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Class II · Moderate risk
Yeast Arrest
cGMP violations