FDARecall 99570Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
Presence of particulate matter: glass and stopper piece
FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.
Is it yours? Products and codes
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
- Lot or code
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- FDA recall number
- D-0803-2026
- Quantity
- 12367 vials
Distribution (FDA): USA Nationwide
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Mallinckrodt Hospital Products Inc.
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.