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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

Sun Pharmaceutical Industries, Inc.: Failed Impurities/Degradation Specifications

Agency Publication Date: September 16, 2016
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Affected Products

Product: 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

Lot #: AVF0246/A, AVF0247/B, AVF0246/B, AVF0246/C; Exp. 02/17

Lot Numbers:
AVF0246
Product: Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only, Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Lot #: AVF0254/C, AVF0254/B, AVF0254/C; Exp. 02/17

Lot Numbers:
AVF0254
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

Lot #: AVF0256/A , AVF0256/B, AVF0256/C; Exp. 02/17

Lot Numbers:
AVF0256
Product: Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Lot # AVF0258/A, AVF0258/B, AVF0258/C, AVF0259/A, AVF0259/C; Exp. 02/17

Lot Numbers:
AVF0258

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 74694
Status: Resolved
Manufacturer: Sun Pharmaceutical Industries, Inc.
Manufactured In: United States
Units Affected: 4 products (4,656 HDPE bottles; 2,952 HDPE bottles; 612 HDPE bottles; 3,889 HDPE bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.