Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Reported: September 28, 2016 Initiated: June 27, 2016 #D-1504-2016
Product Description
Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 4,656 HDPE bottles
- Distribution
- Nationwide
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 4,656 HDPE bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 28, 2016. Severity: Low. Recall number: D-1504-2016.
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