The Recall Desk

FDA (Drugs) recall action 74694

Sun Pharmaceutical Industries, Inc. recalled 4 products on 2016-09-28

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2016-09-28
Critical
0
Units
12,109

Why these products were recalled

Failed Impurities/Degradation Specifications

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Drugs)··2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets because they failed impurity and degradation specifications.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Carvediol Tablets, USP, 25 mg, because the product failed impurities and degradation specifications.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Specifications

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, USP, 6.25 mg, because they failed impurities and degradation specifications.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, 12.5 mg, because they failed impurities and degradation specifications.

    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
    Category
    Distribution
    0 states