Class II · Moderate risk Terminated
Losartan HCTZ 50/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan HCTZ 100/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk Terminated
Losartan HCTZ 100/25 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk Terminated
Mvasi
Reason Defective container: loose crimp defect, potential loss of container integrity.
Class II · Moderate risk Terminated
Xanax XR
Reason Failed Dissolution Specifications: low out of specification results for dissolution.
Class II · Moderate risk Terminated
alprazolam XR extended-release tablets
Reason Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class II · Moderate risk Terminated
GaviLyte -C
Reason Failed Stability Specification
Class II · Moderate risk Terminated
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride
Reason CGMP Deviations
Class II · Moderate risk Terminated
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags
Reason CGMP Deviations
Class II · Moderate risk Terminated
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag
Reason CGMP Deviations
Class II · Moderate risk Terminated
Accupril
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk Terminated
Accupril
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk Terminated
Accupril
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk Terminated
Torco Racing Fuels Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Losartan Potassium & Hydrochlorothiazide Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & Hydrochlorothiazide Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & Hydrochlorothiazide Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Lidocaine 2.5% and Prilocaine 2.5% Cream
Reason cGMP Deviations
Class II · Moderate risk Terminated
Paracentesis/Thoracentises Tray
Reason cGMP deviations: Temperature abuse