Class II · Moderate risk
Glycolic Acid 15% Lotion
Lack of Assurance of Sterility: There are also CGMP Deviations.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Fluocinonide 0.05% Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Fluororacil 0.05% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Erythromycin 2% in Cerave Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Clobetasol 0.05% in Olea Base
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Clindamycin 1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Bleaching Cream 0.1% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Bl 20%/4% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Benzoyl Peroxide 5% Clindamycin 1.2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Adapalene 0.1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Bicarbonate 10%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
MINOXADIL all strength including 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
5-Fluorouracil in Vanicream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Ketoconazole 2%/Hydrocortisone 1.5% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HCG and HCG with resveratrol Human Chorionic Gonadotropin in…
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Human Chorionic Gonadotropin
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Pioglitazone and Glimepiride Tablets
Failed Dissolution Specifications
Class II · Moderate risk
METRONIDazole Injection
Lack of Sterility Assurance: customer report of leaking bag
Class I · High risk
Ibuprofen Lysine Injection
Presence of Particulate Matter
Class II · Moderate risk
CycloSPORINE Capsules
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Levofloxacin Ophthalmic Solution
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Class II · Moderate risk
Indocin (Indomethacin)
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.