Recalls / Class II
Class IID-1213-2015
Product
Losartan potassium tablets USP, 100 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 60505-3162-9
- Affected lot / code info
- Lot #: KT3819, Exp 11/2015; Lot #: KT3821, Exp 11/2015
Why it was recalled
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, Toronto, N/A N/A, Canada
Distribution
- Quantity
- 23,178 bottles
- Distribution pattern
- Nationwide, Hawaii and Puerto Rico
Timeline
- Recall initiated
- 2015-05-29
- FDA classified
- 2015-07-07
- Posted by FDA
- 2015-07-15
- Terminated
- 2017-03-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1213-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.