Class II · Moderate risk
Menastil
cGMP Deviations
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
ProSirona
cGMP Deviations
Class II · Moderate risk
Neuroquell
cGMP Deviations
Class II · Moderate risk
Neuroquell Plus
cGMP Deviations
Class II · Moderate risk
Thiamine Hydrochloride 3000 mg/30 mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
Thiamine Hydrochloride 200 mg/2mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
Quinapril Tablets USP
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk
Quinapril Tablets USP
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil (ibuprofen)
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class III · Low risk
Lacosamide Oral Solution
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Class II · Moderate risk
Desmopressin Acetate Tablet
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Class I · High risk
Iohexol (300 mg Iodine/mL)
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Class II · Moderate risk
Oxcarbazepine Tablets 600mg
Presence of foreign substance
Class I · High risk
Daptomycin for Injection 350 mg/vial 1 Single-dose vial
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Class II · Moderate risk
FentaNYL Citrate 2.5 mg/50 mL
Underfilled units.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container…
Lack of sterility assurance: Bags have the potential to leak.
Class II · Moderate risk
Desmopressin Acetate Tablets 0.2mg
Subpotent Drug
Class II · Moderate risk
Sensorcaine-MPF
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
Sensorcaine
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
Sensorcaine
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class III · Low risk
Allergy Relief D
Failed dissolution specifications