Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
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
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Cura Hongos
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Rapidol
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lil Drug Store
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Circle K
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lucky Super Soft
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lucky Super Soft
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect product formulation: bag did not contain copper and famotidine per label.
Class II · Moderate risk
Minocycline Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Class II · Moderate risk
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Subpotent drug
Class II · Moderate risk
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Subpotent drug
Class II · Moderate risk
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Subpotent drug
Class II · Moderate risk
Gasco Isopropyl Alcohol 70%
Subpotent drug
Class II · Moderate risk
Gasco Isopropyl Alcohol 70%
Subpotent drug
Class II · Moderate risk
Gasco Isopropyl Alcohol 70%
Subpotent drug
Class II · Moderate risk
Budesonide Inhalation Suspension
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Class II · Moderate risk
GSMS Incorporated
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Class II · Moderate risk
BD ChloraPrep FREPP Clear
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations
Class II · Moderate risk
TopCare health
Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk
TopCare health
Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk
EQUALINE ultra strength
Presence of foreign substance: small metallic particles in chewable tablets.