FDAFDA · Food and drugs·Recall number D-0244-2015
Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Published November 12, 2014 · Recall initiated: October 16, 2014
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 Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Inc.
- Distributor
- Nationwide.
- Lot
- Lot #: a) KR3955; Exp. 10/15, KV0430, Exp. 11/15 Lot #: b) KT6063; Exp. 10/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- Canada
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