Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lot FY3669 with expiry 11/2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0515-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 10, 2017
- FDA report date
- Mar 15, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0515-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76515
- Address
- 100 College Rd W
- Code information
- Lot FY3669 with expiry 11/2017
- Postal code
- 08540-6604
- Report date
- Mar 15, 2017
- Product type
- Drugs
- Recall number
- D-0515-2017
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Termination date
- Oct 24, 2017
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 10, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2017