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
18,003 recalls, newest first
Class III · Low risk
Sirolimus Oral Solution
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
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 III · Low risk
Higher Education Make Out Ready Vegan Lip Balm
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
buPROPion Hydrochloride Extended-Release Tablet
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
buPROPion Hydrochloride Extended-Release Tablet
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
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 III · Low risk
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic…
Subpotent drug: Low OOS for menthol content at the three month room temperature.
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.