Mallinckrodt Hospital Products Inc.: Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, ND
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Mallinckrodt Hospital Products Inc.
- Product
- 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
- Reason / hazard
- Presence of particulate matter: glass and stopper piece
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- USA Nationwide
- Recall initiated
- 2026-08-06
- Code info
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Product quantity
- 12367 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bridgewater
- State
- NJ
- Country
- United States
- Event id
- 99570
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