The Recall Desk

FDA (Drugs) recall action 67462

Lupin Pharmaceuticals Inc. recalled 2 products on 2014-04-09

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-04-09
Critical
0
Units
9,210

Why these products were recalled

Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

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.

1–2 of 2

  • LowFDA (Drugs)··2014-04-09

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 4,038 bottles of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.

    Product
    Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-04-09

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failure

    Lupin Pharmaceuticals is recalling specific lots of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.

    Product
    Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.
    Category
    Distribution
    0 states