Recalls / Class III
Class IIID-1506-2016
Product
Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
- Affected lot / code info
- Lot #: AVF0256/A , AVF0256/B, AVF0256/C; Exp. 02/17
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 612 HDPE bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-27
- FDA classified
- 2016-09-16
- Posted by FDA
- 2016-09-28
- Terminated
- 2018-03-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1506-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.