Class II · Moderate risk Ongoing
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant…
Reason CGMP Deviations
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Bicillin L-A
Reason CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk Ongoing
Bicillin L-A
Reason CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk Ongoing
Semaglutide
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Semaglutide
Reason Subpotent Drug
Class III · Low risk Ongoing
Fluorescein 2% Ophth
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Semaglutide
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Cinacalcet Tablets 90 mg
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Tablets
Reason CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Tablets
Reason CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk Ongoing
Rite Aid Pharmacy
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
Good Neighbor Pharmacy
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
H-E-B
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
ReliOn
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
CURAD Alcohol Prep Pads
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
Medline Alcohol Prep Pads
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Peripheral Parenteral Nutrition
Reason 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 Ongoing
Budesonide Inhalation Suspension
Reason Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II · Moderate risk Ongoing
Omeprazole Delayed-release Capsules
Reason Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I · High risk Ongoing
Buffered Penicillin G Potassium for Injection
Reason Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class I · High risk Ongoing
Cefazolin for Injection
Reason Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Failed Impurity/Degradation Specifications