FDA (Drugs) recall action 70001
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
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 Elizabeth LLC is recalling GABA 300-EZS (Gabapentin) capsules distributed in Puerto Rico due to reports of clumping, breaking, and packaging defects.
Actavis Elizabeth LLC is recalling specific lots of Gabapentin 400 mg capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.
Actavis Elizabeth LLC is recalling 29,622 bottles of Gabapentin capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.