Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
FDA Drug Recalls
37 recalls, newest first
Class II · Moderate risk
Mupirocin Ointment
Subpotent Drug
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class II · Moderate risk
Hand-I-San
CGMP Deviations: sterile water not used for production
Class II · Moderate risk
Rubbing Alcohol
CGMP Deviations: sterile water not used for production
Class III · Low risk
Methotrexate Tablets
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class II · Moderate risk
Budesonide
CGMP Deviations and Presence of Particulate Matter: Glass
Class II · Moderate risk
Phenazopyridine HCl Tablets USP
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications
Class III · Low risk
Fentanyl 1000mcg/100mL
Labeling: Wrong Barcode
Class I · High risk
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Class III · Low risk
Valacyclovir Tablets USP
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class II · Moderate risk
Progesterone 200 mg
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class II · Moderate risk
Gordofilm Wart Remover
cGMP Deviations
Class III · Low risk
NEXLIZET (bempedoic acid and ezetimibe)
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class II · Moderate risk
Methylergonovine Maleate Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Sterile Diluent
CGMP Deviations
Class II · Moderate risk
S.P Labs
Failed Stability Specifications
Class II · Moderate risk
S.P.Labs
Failed Stability Specifications
Class II · Moderate risk
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Subpotent Drug: Out of specification for assay
Class I · High risk
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid
Chemical Contamination; presence of benzene.
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.