FDA (Drugs) recall action 69237
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 Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
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.
Actavis is recalling 36,538 bottles of Diclofenac Sodium and Misoprostol tablets due to complaints of split or broken tablets.
Actavis is recalling 6,041 bottles of Diclofenac Sodium and Misoprostol tablets because they may be split or broken.