Class II · Moderate risk
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan HCTZ 100/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
Losartan HCTZ 100/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
MVASI (bevacizumab-awwb)
Defective container: loose crimp defect, potential loss of container integrity.
Class II · Moderate risk
Xanax XR (alprazolam)
Failed Dissolution Specifications: low out of specification results for dissolution.
Class II · Moderate risk
alprazolam XR extended-release tablets
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class II · Moderate risk
GaviLyte -C
Failed Stability Specification
Class II · Moderate risk
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag
CGMP Deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules USP
cGMP deviations
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk
Erythromycin Topical Gel USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Betamethasone Dipropionate Ointment USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Lidocaine Prilocaine Cream USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Lidocaine Hydrochloride Topical Solution USP 4%
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Halobetasol Propionate Ointment 0.05% Net Wt.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Torco Racing Fuels Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Losartan Potassium & Hydrochlorothiazide Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits