FDAFDA · Food and drugs·Recall number D-0288-2015
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
Published December 10, 2014 · Recall initiated: October 2, 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: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz, Inc
- Distributor
- Nationwide
- Lot
- Lot #: 3007330, Exp 11/2014
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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