Acthar Gel 400 USP units/5mL Recall: CGMP Deviations
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Acthar Gel 400 USP units/5mL recalled?
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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
Which lot codes, UPCs or models are affected?
Lot #: 1564-103, Exp 9/30/2024
- Agency record number
- D-0340-2024
- Product
- Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC…
- Recalling firm
- Mallinckrodt Hospital Products Inc.
- Quantity
- 8 vials involved in recall (16,479 vials distributed)
- Distribution
- USA nationwide
- Recall started
- February 6, 2024
- Report date
- February 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)