FDA (Drugs) recall action 97103
The FDA (Drugs) publishes a recall like this one as 7 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 7 pages.
Subpotent Drug: Assay below the approved specification
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.
Levothyroxine Sodium Tablets, USP 175 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 2,344 bottles affected.
Levothyroxine Sodium Tablets, USP 50 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 54,227 bottles affected.
Levothyroxine Sodium Tablets, USP 25 mcg in 1000-count bottles from Accord Healthcare are being recalled because the product is subpotent. 2,352 bottles are affected.
Levothyroxine Sodium Tablets, USP 100 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 9,739 bottles affected.
Levothyroxine Sodium Tablets, USP 150 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,921 bottles affected.
Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.
Levothyroxine Sodium Tablets, USP 112 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,896 bottles affected.