FDA 将 Mallinckrodt Acthar Gel 颗粒污染召回列为 II 类（D-0803-2026）

FDA drug recall enforcement report — D-0803-2026

Report issued: 2026-09-02. This is the enforcement report date, not the recall initiation date.

Scope: one classified drug product recall record; event_id may group multiple products. Unclassified records without recall numbers are outside this stream. This record is not a press release or a new enforcement finding.

The openFDA dataset is updated weekly. Report status is not a live recall status and must not be used to track the recall lifecycle. Other dates below retain their named meanings.

Complete official product record (including openFDA harmonized identifiers):

{

"address_1": "440 Us Highway 22 Ste 302",

"address_2": "N/A",

"center_classification_date": "20260826",

"city": "Bridgewater",

"classification": "Class II",

"code_info": "Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027",

"country": "United States",

"distribution_pattern": "USA Nationwide",

"event_id": "99570",

"initial_firm_notification": "Letter",

"openfda": {},

"postal_code": "08807-2477",

"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",

"product_quantity": "12367 vials",

"product_type": "Drugs",

"reason_for_recall": "Presence of particulate matter: glass and stopper piece",

"recall_initiation_date": "20260806",

"recall_number": "D-0803-2026",

"recalling_firm": "Mallinckrodt Hospital Products Inc.",

"report_date": "20260902",

"state": "NJ",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}