Class III · Low risk Ongoing
Glimepiride Tablets
Reason Misprint on tablet
Pioglitazone and Glimepiride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
What was recalled
Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
- Recalling firm
- Sandoz Inc
- NDC code
- 0781-5635-31
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0515-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Glimepiride recalls
See all
Class III · Low risk Ongoing
Glimepiride Tablets
Reason Misprint on tablet
Class II · Moderate risk Terminated
Glimepiride USP
Reason CGMP deviations.
Class II · Moderate risk Ongoing
Glimepiride Tablets USP
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Glimepiride Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
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