Class II · Moderate risk Terminated
Conzerol zero molluscum contagiosum
Reason CGMP deviations
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Timolol-Latanoprost
Reason Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution
Reason cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk Terminated
Carvedilol Tablets
Reason Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Class III · Low risk Terminated
Susvimo
Reason Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Reason Presence of Foreign Substance
Class III · Low risk Terminated
Fyarro
Reason Failed Stability Specifications
Class III · Low risk Terminated
NDC 0363-6171-09 Walgreens Sinus Pressure
Reason Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class I · High risk Terminated
Octreotide Acetate Injection 500 mcg/mL
Reason Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Class II · Moderate risk Terminated
Rifampin Capsules
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk Terminated
Rifampin Capsules
Reason Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class II · Moderate risk Terminated
Fondaparinux Sodium Injection
Reason Subpotent Drug: Out of specification for assay
Class II · Moderate risk Terminated
Pyridostigmine Bromide Oral Solution
Reason cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Class II · Moderate risk Terminated
Arformoterol Tartrate Inhalation Solution
Reason Lack of Assurance of Sterility: environmental monitoring failure.
Class I · High risk Terminated
Atenolol Tablets
Reason Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Class II · Moderate risk Terminated
Aminophylline Injection
Reason Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class III · Low risk Terminated
oxyTOCIN 30 Units/500 mL
Reason Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets
Reason Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Class III · Low risk Terminated
Xolegel
Reason Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Class II · Moderate risk Terminated
Neoral soft gelatin capsules
Reason CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.