Class II · Moderate risk
Myxredlin
CGMP Deviations
Diabetes Medication Recalls
Recalls of metformin and other drugs used to control blood sugar - metformin extended-release was recalled over the same nitrosamine impurity as valsartan.
161 recalls in this category, newest first.
Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets 1000mg
CGMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended- Release 500mg
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Class II · Moderate risk
glipiZIDE
Failed Dissolution Specifications:
Class II · Moderate risk
Sterile Diluent
CGMP Deviations
Class III · Low risk
Glimepiride Tablets
Misprint on tablet
Class III · Low risk
Glimepiride Tablets
Misprint on tablet
Class II · Moderate risk
Admelog
Lack of Assurance of Sterility: Malformed crimped collar seal
Class II · Moderate risk
Glimepiride USP
CGMP deviations.
Class II · Moderate risk
Glimepiride Tablets USP
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Glimepiride Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Glimepiride 2 mg tablets
cGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
Class II · Moderate risk
Glimepiride
cGMP deviations
Class II · Moderate risk
Glimepiride
cGMP deviations
Class II · Moderate risk
Glimepiride
cGMP deviations
Class II · Moderate risk
JARDIANCE (Empagliflozin)
Labeling: Label Mix-up
Class II · Moderate risk
Metformin hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Glimepiride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
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