Class II · Moderate risk
Acthar Gel
Presence of particulate matter: glass and stopper piece
National Drug Code
Is NDC 63004-8710-02 recalled?
Acthar · 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE
Yes — this exact package was recalled
1 FDA recall names the code 63004-8710-02 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
2 of these recalls are still ongoing.
- Active ingredient
- Repository Corticotropin
- Strength
- CORTICOTROPIN 80 [USP'U]/mL
- Form
- Injection · Intramuscular, Subcutaneous
- Labeler
- Mallinckrodt ARD LLC
- Type
- Human Prescription Drug
- Product code
- 63004-8710
Recalls naming this package
Class II · Moderate risk
Acthar Gel
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
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