Mallinckrodt recalls Acthar Gel injections due to temperature excursions during shipping. Affected lots may be unsafe if not stored properly. Check your product details to see if you're impacted.
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Mallinckrodt is recalling Acthar Gel injections that may have been exposed to incorrect temperatures during shipping. This could affect the medication's safety and effectiveness if not properly stored.
Temperature excursions during shipping could cause the medication to become unstable. This might affect the product's safety and effectiveness, though the recall does not specify serious injury risks.
Prescription users of Acthar Gel injections who received the specific lot number 1564-103 from Mallinckrodt ARD LLC. Patients with autoimmune conditions requiring this medication are most at risk.
Check for the lot number 1564-103 on the Acthar Gel vial. The product is a 5mL multiple-dose vial with 400 USP units/5mL (80 USP units/mL) that requires a prescription.
Look for the lot number 1564-103 on the Acthar Gel vial to confirm if it's affected.
The recall does not state that the product is unsafe; it indicates potential temperature issues during shipping that could affect safety and effectiveness.
Check the lot number on the vial; affected products have lot number 1564-103.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Mallinckrodt to request your refund or repair — edit it as you like.
Subject: Recall D-0340-2024 — Mallinckrodt Mallinckrodt Hello, I own a Mallinckrodt that is covered by recall D-0340-2024 from Mallinckrodt. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
