FDA (Drugs) recall action 93945
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.
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
The agency’s own wording, quoted from the enforcement report.
Acthar Gel (repository corticotropin injection) is being recalled due to a temperature excursion during shipping from the manufacturer to distributor. Lot #1564-103 should not be dispensed to patients.
Mallinckrodt recalls TERLIVAZ (terlipressin) injection due to temperature excursion during shipping. A cGMP deviation may compromise drug stability.