AMIVAS (US), LLC recalls Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials…
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Read the official notice →- Date
- 2021-10-13
- Country
- United States
- Brand
- AMIVAS (US), LLC
- Product
- Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials…
- Classification
- Class II
- Units
- Product was distributed to 3 major distributors who may have further…
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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FDA · DeviceDatascope Corp.Nationwide domestic distribution. Foreign distribution worldwide.Official notice →