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
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540
Affected NDCs
42571-0101-01
42571-0101-05
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 42571-0101 |
2 mg/1 | Tablet Oral |
Micro Labs Limited | Rx |
- Recalling firm
- Micro Labs Usa, Inc S
- NDC code
- 42571-101-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0046-2015 · 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 Micro Labs Usa, Inc S
All 2014 recalls
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class II · Moderate risk
Losartan Potassium Tablets USP
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
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