Class III
Terminated
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
This recall has been terminated (originally issued February 17, 2016).
- Company
- Sandoz Inc
- Recall Initiated
- December 31, 2015
- Posted
- February 17, 2016
- Recall Number
- D-0659-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 277,267 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Distribution
Nationwide
Lot / Code Info
a) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017
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