candesartan cilexetil recall: Impurity Out of Spec
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited…
Why was candesartan cilexetil recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3007330, Exp 11/2014
- Product
- candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited…
- Recalling firm
- Sandoz, Inc
- Quantity
- 6,336 bottles
- Distribution
- Nationwide
- Recall date
- December 10, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)