Class II · Moderate risk
Progesterone Modified Release 200 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
FDA Drug Recalls
708 recalls · Class II, newest first
Class II · Moderate risk
Progesterone Modified Release 100 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 50 mg Modified Release Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 200 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 300 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 150 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Minoxidil/Biotin 1.25mg/5mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Finasteride Plus 1.25mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 8 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 6 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
D-Biotin 300 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Calcium citrate tetrahydrate USP powder
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Cefdinir for Oral Suspension USP
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class II · Moderate risk
Lidothol Patch
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class II · Moderate risk
Carbamazepine 200 mg Tablets
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Class II · Moderate risk
Cetrotide (cetrorelix acetate for Injection)
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Class II · Moderate risk
Saniderm ADVANCED HAND SANITIZER
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Class II · Moderate risk
Metformin HCl Extended Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Childrens Dimetapp Cold & Cough
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class II · Moderate risk
Childrens Robitussin Honey Cough and Chest Congestion DM
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.