PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 15, 2017 Initiated: February 10, 2017 #D-0515-2017

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

Reason for Recall

Failed Dissolution Specifications

Details

Recalling Firm
Sandoz Inc
Units Affected
N/A
Distribution
Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product 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. Recalled by Sandoz Inc. Units affected: N/A.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on March 15, 2017. Severity: Moderate. Recall number: D-0515-2017.