Class III · Low risk
Glimepiride Tablets
Misprint on tablet
Glimepiride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Affected NDCs
51655-0120-26
51655-0120-52
Compare with the code on your package — it is the most precise check available.
Drug: Glimepiride Category: Diabetes Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Glimepiride NDC 51655-0120 |
4 mg/1 | Tablet Oral |
Northwind Health Company, LLC | Rx |
- Recalling firm
- Northwind Pharmaceuticals LLC
- NDC code
- 51655-120-52
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0552-2023 · 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.
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 Northwind Pharmaceuticals LLC
All 2023 recalls
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
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