FDA (Drugs) recall action 67971
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.
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.
Caraco Pharmaceutical Laboratories is recalling specific lots of Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing.
Caraco Pharmaceutical Laboratories is recalling 47,813 bottles of Children's Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing for N-Oxide.