FDA (Drugs) recall action 67928
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.
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
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.
Boehringer Ingelheim Roxane Inc. is recalling Mercaptopurine Tablets USP because they were labeled with 36-month expiration dates instead of the approved 24 months.
Boehringer Ingelheim Roxane Inc is recalling 8,304 bottles of Azathioprine Tablets USP, 50 mg, because they were labeled with 36-month expiration dates instead of the approved 24 months.