United StatesActhar Gel (repository corticotropin injection), 5 mL multiple‑dose vials (Rx Only) manufactured for Mallinckrodt ARD LLC — NDC 63004-8710-1 (Lot 1564-107) and NDC 63004-8710-2 (Lot 1564-107H), exp 1/31/2027 — is being recalled in the United States (12,367 vials). The recall was issued because particulate matter, including glass and a stopper piece, was found in the vials.
What's being recalled
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Recalling firm: Mallinckrodt Hospital Products Inc., Bridgewater, NJ, United States.
How to identify it
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
The hazard
Presence of particulate matter: glass and stopper piece
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
USA Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)