Drug product
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
D-0515-2017
Product summary
- Firm
- Sandoz Inc
- Event
- Event 76515
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0515-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot FY3669 with expiry 11/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications