Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, N…
Mallinckrodt Hospital Products Inc. · Presence of particulate matter: glass and stopper piece
- Status
- Ongoing
- City
- Bridgewater
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99570
- Recalling firm
- Mallinckrodt Hospital Products Inc.
- Address 1
- 440 Us Highway 22 Ste 302
- Address 2
- N/A
- Postal code
- 08807-2477
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
- Recall number
- D-0803-2026
- Product quantity
- 12367 vials
- Reason for recall
- Presence of particulate matter: glass and stopper piece
- Recall initiation date
- 20260806
- Center classification date
- 20260826
- Report date
- 20260902
- Code info
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Product description
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
- Harmonized identifiers (openFDA)
- Application number
- NDA008372
- Brand name
- ACTHAR
- Generic name
- REPOSITORY CORTICOTROPIN
- Manufacturer name
- Mallinckrodt ARD LLC
- Product NDC
- 63004-8710, 63004-8712, 63004-8711
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, SUBCUTANEOUS
- Substance name
- CORTICOTROPIN
- RxCUI
- 309541, 1040025, 2685293, 2685296, 2685298, 2685299
- SPL ID
- c63a790c-ec8a-4037-bbd3-cfe75cdd81ab
- SPL set ID
- 7b48ddec-e815-45f4-9ca0-5c0daaf56f30
- Package NDC
- 63004-8710-1, 63004-8710-2, 63004-8712-1, 63004-8712-4, 63004-8711-1, 63004-8711-4
- Is original packager
- true
- Upc
- 0363004871213
- Nui
- M0000499, N0000175941
- Pharm class cs
- Adrenocorticotropic Hormone [CS]
- Pharm class epc
- Adrenocorticotropic Hormone [EPC]
- UNII
- K0U68Q2TXA