Class II · Moderate risk
Gemcitabine
Lack of Assurance of Sterility
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Edetate Disodium
Lack of Assurance of Sterility
Class II · Moderate risk
Edetate Disodium
Lack of Assurance of Sterility.
Class II · Moderate risk
Dexamethasone sodium phosphate
Lack of Assurance of Sterility
Class II · Moderate risk
Cefuroxime
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftazidime
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl/Epinephrine
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Sterile Buffered Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
ALUM Concentrate
Lack of Assurance of Sterility
Class II · Moderate risk
Extra Strength Headache
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk
Medique Pain-Off
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk
Physicians CARE Extra Strength PAIN RELIEVER
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class I · High risk
kleantouch HAND SANITIZER
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class III · Low risk
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree sample boxes
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx36 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx26 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx21 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx7 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Labeling: Missing Label
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg per 5 mL
Labeling: Missing Label
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class II · Moderate risk
B-Complex
Lack of Processing Controls