Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01)
Summary
The FDA issued a Class II for Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Sing by AMIVAS (US), LLC. Reason: Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance..
Details
Source
Drug Recall
External ID
D-0002-2022
Action Date
2021-10-13
Status
Terminated
Category
drug
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.
Lot/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
Quantity Affected: 292 cartons
Reason for Recall
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-27
Company
Frederick, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AMIVAS (US), LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AMIVAS (US), LLC have FDA actions?
This is the only FDA action we have on record for AMIVAS (US), LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0002-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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