Class III · Low risk
Glimepiride Tablets
Misprint on tablet
Glimepiride Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
Affected NDC
0603-3745-21
Compare with the code on your package — it is the most precise check available.
Drug: Glimepiride Category: Diabetes Medication
- Recalling firm
- Qualitest Pharmaceuticals
- NDC code
- 0603-3745-21
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-298-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Glimepiride recalls
See all
Class III · Low risk
Glimepiride Tablets
Misprint on tablet
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.
Other recalls by Qualitest Pharmaceuticals
All 2013 recalls
Class III · Low risk
Allopurinol Tablets
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Class III · Low risk
HydrOXYzine Hydrochloride Tablets
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class III · Low risk
Disulfiram tablets
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Class III · Low risk
Promethazine Vc With Codeine Syrup
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
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