Why it was recalled
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
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 numbers, UPCs & expiration codes
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
Where it was sold
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 to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0002-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2021
- FDA report date
- Oct 13, 2021
- Quantity
- 292 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AMIVAS (US), LLC
Original FDA data
Every field from FDA enforcement report D-0002-2022, exactly as published.
Show all FDA fields
- City
- Frederick
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 88772
- Address
- 100 Tuscanney Dr Suiteb2
- Code information
- 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
- Postal code
- 21702
- Report date
- Oct 13, 2021
- Product type
- Drugs
- Recall number
- D-0002-2022
- Classification
- Class II
- Recalling firm
- AMIVAS (US), LLC
- Product quantity
- 292 cartons
- Termination date
- Jun 27, 2023
- Reason for recall
- Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- 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.
- Recall initiation date
- Sep 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2021