Class II · Moderate risk
Timolol-Latanoprost
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Class III · Low risk
Susvimo (ranibizumab injection)
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
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Presence of Foreign Substance
Class III · Low risk
Fyarro (albumin-bound)
Failed Stability Specifications
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class I · High risk
Octreotide Acetate Injection 500 mcg/mL
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Class II · Moderate risk
Rifampin Capsules
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk
Rifampin Capsules
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
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
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class II · Moderate risk
Pyridostigmine Bromide Oral Solution
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Class II · Moderate risk
Arformoterol Tartrate Inhalation Solution
Lack of Assurance of Sterility: environmental monitoring failure.
Class I · High risk
Atenolol Tablets
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Class II · Moderate risk
Aminophylline Injection
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class II · Moderate risk
Ampicillin for Injection
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class III · Low risk
oxyTOCIN 30 Units/500 mL
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
Clonidine Hydrochloride Tablets
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
Xolegel (ketoconazole)
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class II · Moderate risk
Budesonide Inhalation Suspension 0.25mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Lisinopril 10 mg tablets
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class I · High risk
Antica Farmacista Hand Sanitizer Ocean Citron
Chemical Contamination: product found to contain benzene