PlainRecalls
FDA Drug Moderate Class II Terminated

Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9

Reported: July 15, 2015 Initiated: May 29, 2015 #D-1212-2015

Product Description

Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9

Reason for Recall

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Details

Recalling Firm
Apotex Inc.
Units Affected
45,708 bottles
Distribution
Nationwide, Hawaii and Puerto Rico
Location
Toronto, N/A

Frequently Asked Questions

What product was recalled?
Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9. Recalled by Apotex Inc.. Units affected: 45,708 bottles.
Why was this product recalled?
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 15, 2015. Severity: Moderate. Recall number: D-1212-2015.