Class II · Moderate risk Terminated
Cefuroxime
Reason Lack of Assurance of Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Ceftazidime
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl/Epinephrine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl Sterile Buffered Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ALUM Concentrate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Extra Strength Headache
Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Medique Pain-Off
Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Physicians CARE Extra Strength PAIN RELIEVER
Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class I · High risk Terminated
kleantouch HAND SANITIZER
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class III · Low risk Terminated
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CariFree sample boxes
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx36 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx26 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx21 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx7 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason Labeling: Missing Label
Class III · Low risk Terminated
Morphine Sulfate Oral Solution 100 mg per 5 mL
Reason Labeling: Missing Label
Class I · High risk Terminated
Veklury
Reason Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class II · Moderate risk Terminated
B-Complex
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Methylcobalamin 12mg/ml injection
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Carbamazepine Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Telmisartan and Hydrochlorothiazide Tablets
Reason Superpotent; Hydrochlorothiazide
Class I · High risk Terminated
Klean Touch Hand Sanitizer
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class II · Moderate risk Ongoing
Lidocaine Hydrochloride
Reason Superpotent Drug: Minimally superpotent