Class II · Moderate risk
Fluororacil 0.05% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
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.
14,543 recalls, newest first.
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 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 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.
Class II · Moderate risk
Glipizide 2.5 mg ER Tablets
Failed Dissolution Specifications
Class II · Moderate risk
GlipiZIDE Extended-release tablets
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
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
Transderm Scop
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.