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.
FDA Drug Recalls
2,277 recalls · Class II, newest first
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 II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Class II · Moderate risk Ongoing
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Defective container; blister packaging inadequately sealed.
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Defective container; blister packaging inadequately sealed.
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).