Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
FDA Drug Recalls
1,724 recalls · Class II, newest first
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
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 3.75mg / Ipratropium 0.75mg
Lack of Processing Controls
Class II · Moderate risk
Budesonide 0.4mg
Lack of Processing Controls
Class II · Moderate risk
Formoterol 12mcg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
R2103
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
StellaLife VEGA Oral Gel Rinse
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Pareira (Brava)
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Silicea 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Sulphuricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Muriaticum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.