Reported Sep 28, 2016 · Terminated
Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count…
Sun Pharmaceutical Industries, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
Carvediol TabletsUSP25 mg100-count bottle (NDC 57664-247-88)500-count bottle (NDC 57664-247-13)1000-count bottle (NDC 57664-247-18)
- Rx Only Manufactured byALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary
- Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
- Lot codes and dates
Lot # AVF0258/AAVF0258/BAVF0258/CAVF0259/AAVF0259/CExp. 02/17
- Amount recalled
- 3,889 HDPE bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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