FDA (Drugs) recall action 64312
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: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
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.
Watson Laboratories is recalling meprobamate 200 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.
Watson Laboratories is recalling meprobamate 400 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.