Class II · Moderate risk
HCG 500 units/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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
HCG 2000 units/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
HCG 1000 units/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Gentamicin buffered 36.4 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Estradiol Valerate 30 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Estradiol Valerate 20 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Estradiol Cypionate 5 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Diazepam 5 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cyclosporine 2% ophthalmic
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cyclosporine 1% ophthalmic drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cataract drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 2 % Solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 20 % solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 10 % Solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Donnatal Extentabs
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
Class II · Moderate risk
Ethambutol Hydrochloride Tablets
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Class II · Moderate risk
"Well at Wallgreens" Regular Strength Antacid Liquid
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Class II · Moderate risk
All Compounded Products
Lack of Assurance of Sterility; potential for mold contamination
Class II · Moderate risk
Avastin
Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer
Class II · Moderate risk
Oxiracetam & Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
BoostYourGrade.com
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Brain Defogger
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Piracetam & Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Aniracetam and Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs