FDA (Drugs) recall action 98275
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.
Superpotent and Subpotent
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.
Teva is recalling three lots of Isotretinoin Capsules, USP, 30 mg because the product was found to be superpotent and subpotent. 21,984 packages are affected.
Teva is recalling three lots of Isotretinoin Capsules, USP, 40 mg because the product was found to be superpotent and subpotent. 8,376 packages are affected.