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
Reported: February 17, 2016 Initiated: December 31, 2015 #D-0659-2016
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 277,267 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Inc. Units affected: 277,267 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 17, 2016. Severity: Low. Recall number: D-0659-2016.
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