Class II · Moderate risk
Acthar Gel
Presence of particulate matter: glass and stopper piece
Acthar Gel (Repository Corticotropin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
Affected NDC
63004-8710-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Acthar Repository Corticotropin NDC 63004-8710 |
CORTICOTROPIN 80 [USP'U]/mL | Injection Intramuscular|subcutaneous |
Mallinckrodt ARD LLC | Rx |
- Recalling firm
- Mallinckrodt Hospital Products Inc.
- NDC code
- 63004-8710-1
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0340-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Mallinckrodt Hospital Products Inc.
All 2024 recalls
Class II · Moderate risk
Terlivaz (terlipressin for injection)
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Other temperature excursion recalls from 2024
All temperature excursion recalls
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Class II · Moderate risk
Hylenex recombinant
cGMP Deviations: Temperature excursion
Class II · Moderate risk
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide)
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Class II · Moderate risk
Terlivaz (terlipressin for injection)
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
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