FDAFDA · Food and drugs·Recall number D-0242-2015
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
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 # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- Canada
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