The Recall Desk

FDA (Drugs) recall action 67971

Caraco Pharmaceutical Laboratories, Ltd. recalled 2 products on 2014-05-07

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
2014-05-07
Critical
0
Units
176,176

Why these products were recalled

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

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

  • ModerateFDA (Drugs)··2014-05-07

    Caraco Recalls Children's Cetirizine Tablets Due to Impurity Failures

    Caraco Pharmaceutical Laboratories is recalling 47,813 bottles of Children's Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing for N-Oxide.

    Product
    Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-05-07

    Caraco Recalls Cetirizine Hydrochloride Chewable Tablets Due to Impurities

    Caraco Pharmaceutical Laboratories is recalling specific lots of Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing.

    Product
    Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
    Category
    Distribution
    0 states