FDAFDA · Food and drugs·Recall number D-1215-2015
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
Published July 15, 2015 · Recall initiated: May 29, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Inc.
- Distributor
- Nationwide, Hawaii and Puerto Rico
- Lot
- Lot #: KP4529, Exp 10/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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