FDA (Drugs) recall action 87266
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
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.
Teligent Pharma is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) because the product failed impurity specifications.
Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% because it failed impurity specifications for a known degradation product.
Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurity specifications. The product is distributed nationwide in 15-gram tubes.