FDA (Drugs) recall action 98136
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 Specification: There is a potential for the imprint to be missing on 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.
SpecGx is recalling 287,988 bottles of Oxycodone and Acetaminophen CII Tablets, 10 mg/325 mg, because of the potential for the imprint to be missing on tablets.
SpecGx is recalling 74,544 bottles of Oxycodone and Acetaminophen CII Tablets, 7.5 mg/325 mg, because of the potential for the imprint to be missing on tablets.