Class II · Moderate risk Terminated
Losartan HCTZ 100/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
FDA Drug Recalls
14,801 recalls, newest first
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 III · Low risk Terminated
Higher Education Make Out Ready Vegan Lip Balm
Reason Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablet
Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablet
Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
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 III · Low risk Terminated
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic…
Reason Subpotent drug: Low OOS for menthol content at the three month room temperature.
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 I · High risk Terminated
Tacrolimus
Reason Subpotent drug
Class I · High risk Terminated
Tacrolimus
Reason Subpotent drug
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Lidocaine Hydrochloride Oral Topical Solution
Reason Failed viscosity specification - product was below specificcation
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