Class II · Moderate risk
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
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
Epinephrine Lidocaine HCL
Sub-Potent Drug: Subpotent assay results during stability testing.
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
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027