Class II · Moderate risk Terminated
Erythromycin 2% in Cerave Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Clobetasol 0.05% in Olea Base
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Clindamycin 1%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Bleaching Cream 0.1% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Bl 20%/4% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Benzoyl Peroxide 5% Clindamycin 1.2%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Adapalene 0.1%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Bicarbonate 10%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
MINOXADIL all strength including 2%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
5-Fluorouracil in Vanicream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Ketoconazole 2%/Hydrocortisone 1.5% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
HCG and HCG with resveratrol Human Chorionic Gonadotropin in…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Pioglitazone and Glimepiride Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
METRONIDazole Injection
Reason Lack of Sterility Assurance: customer report of leaking bag
Class I · High risk Terminated
Ibuprofen Lysine Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
CycloSPORINE Capsules
Reason Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Levofloxacin Ophthalmic Solution
Reason Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Class II · Moderate risk Terminated
Indocin
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Class II · Moderate risk Terminated
Glipizide 2.5 mg ER Tablets
Reason Failed Dissolution Specifications
Class I · High risk Terminated
Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class I · High risk Terminated
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only
Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.