Class III
Terminated
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
- Company
- Sandoz Inc
- Recall Initiated
- October 2, 2014
- Posted
- December 10, 2014
- Recall Number
- D-0288-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,336 bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Lot #: 3007330, Exp 11/2014
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