Class III · Low risk
Cetirizine HCl Chewable Tablet
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
FDA Drug Recalls
1,711 recalls, newest first
Class III · Low risk
Flurandrenolide Tape
Subpotent Drug: Flurandrenolide is subpotent.
Class I · High risk
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP 25
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class II · Moderate risk
Ketorolac Tromethamine Inj. USP
Crystallization
Class II · Moderate risk
Ketorolac Tromethamine Inj. USP
Crystallization
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class I · High risk
Testosterone Cypionate 200 mg/mL in Sesame oil
Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL.
Class III · Low risk
ImproVue Ophthalmic Lubricant Drops
Failed pH specification
Class III · Low risk
Monistat 1 Simple Cure
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
Class II · Moderate risk
Hydroxyzine Hydrochloride
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Hydroxyzine Hydrochloride
Failed Impurities/Degradation Specifications
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Class II · Moderate risk
C-Topical 4% CII
Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Class III · Low risk
Cartia XT (diltiazem HCl extended-release capsules, USP)
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Class III · Low risk
Promethazine Vc With Codeine Syrup
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.