FDA recall D-1215-2015

Product

Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-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 60505-0209-1

Reason for recall

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

Distribution

Nationwide, Hawaii and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-05-29

Report date

2015-07-15

Termination date

2017-03-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1215-2015