Reported Feb 28, 2024 · Ongoing
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only,…
Mallinckrodt Hospital Products Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mallinckrodt Hospital Products Inc. · 440 Us Highway 22 · Bridgewater, NJ · 08807-2477
Is this the product you have?
- Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd
- forMallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
- Lot codes and dates
Lot #: 1564-103Exp 9/30/2024
- Amount recalled
- 8 vials involved in recall (16,479 vials distributed)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
This product could cause temporary or reversible health problems — stop using it.
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