Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
Sucralfate Tablets
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II · Moderate risk
Shave and Skincare Power Stick Original Nourishing Invisible…
CGMP Deviations
Class II · Moderate risk
Beauty & Skincare Power Stick original nourishing invisible…
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class II · Moderate risk
Cinacalcet Tablets 90 mg
Failed Dissolution Specifications.
Class II · Moderate risk
Rizatriptan Benzoate Tablets
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Rizatriptan Benzoate Tablets
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Rite Aid Pharmacy
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
Good Neighbor Pharmacy
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
H-E-B
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
ReliOn
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
CURAD Alcohol Prep Pads
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
Medline Alcohol Prep Pads
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II · Moderate risk
Peripheral Parenteral Nutrition
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Class II · Moderate risk
Budesonide Inhalation Suspension
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.