Class III · Low risk
Spiriva HandiHaler
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
FDA Drug Recalls
1,273 recalls, newest first
Class I · High risk
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes
Superpotent Drug: Product contains twice the stated amount of midazolam.
Class II · Moderate risk
Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes
First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).
Class III · Low risk
Demerol
Labeling; Missing label; ampoules are missing the immediate container label
Class I · High risk
Esmeralda
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Class I · High risk
Maxi Gold Weight Loss Pill
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Class I · High risk
New Life Nutritional SUPER FAT BURNER
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Class II · Moderate risk
METHYLDOPA Tablets USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL CR (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL CR (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
Paroxetine HCL Controlled-Release Tablets 37.5 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
Paroxetine HCL Controlled-Release Tablets 25 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
Paroxetine HCL Controlled-Release Tablets 12.5 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
INDOMETHACIN Capsules USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Class II · Moderate risk
INDOMETHACIN Capsules USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk
ParaGard T 380A - Intrauterine Copper Contraceptive
Non-sterility: due to a failed sterility test
Class III · Low risk
Risperidone Oral Solution
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Class II · Moderate risk
Ranitidine Tablets USP
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.