Recall Enforment Report D-0002-2022

Drug Recall Enforcement Report Class II voluntary initiated by AMIVAS (US), LLC, originally initiated on 09-27-2021 for the product Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801. The product was recalled due to lack of assurance of sterility: air filter failed post integrity test leading to a lack of sterility assurance.. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88772 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0002-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Product was distributed to 3 major distributors who may have further distributed the product to various medical centers, hospitals and hospital pharmacies nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.
Reason For Recall Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 292 cartons Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 10-13-2021
Recall Initiation Date 09-27-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm AMIVAS (US), LLC
Code Info Manufacturer Lot Numbers: AR479E01, exp. date 11/03/2022; AR479E02, exp. date 11/09/2022; AR479E03, exp. date 11/16/2022; Cardinal Health Packaging Solutions Lot Numbers: 7507001 and 7508001 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status Ongoing