FDA (Drugs) recall action 96415
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.
Cross Contamination
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.
Sun Pharmaceutical Industries Inc. is recalling Gabapentin Capsules 400 mg due to cross contamination. The recall affects 852 bottles distributed nationwide.
Sun Pharmaceutical Industries is recalling Gabapentin Capsules, USP 300 mg, due to cross contamination. The recall affects approximately 12,876 bottles distributed nationwide.