Class II · Moderate risk
triple therapy
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
FDA Drug Recalls
1,055 recalls · Class II, newest first
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Class II · Moderate risk
HydrOXYzine Hydrochloride Oral Solution
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Class II · Moderate risk
Tyvaso (treprostinil)
Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
Class II · Moderate risk
Potassium Chloride for Inj. Concentrate
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
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 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 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.
Class II · Moderate risk
Polidocanol 3% Solution
Presence of Particulate Matter
Class II · Moderate risk
Phosphatidylcholine Solution for Injection
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.