Recalls / Class II
Class IID-0515-2017
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
- Affected lot / code info
- Lot FY3669 with expiry 11/2017
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, N/A, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-10
- FDA classified
- 2017-03-09
- Posted by FDA
- 2017-03-15
- Terminated
- 2017-10-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0515-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.