| Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|
| Wainua | eplontersen | 12/21/2023 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Filsuvez | birch triterpenes | 12/18/2023 | To treat wounds associated with dystrophic and junctional epidermolysis bullosa |
| Fabhalta | iptacopan | 12/5/2023 | To treat paroxysmal nocturnal hemoglobinuria |
December 27, 2023
Date |
Brand Name(s) |
Description |
Type |
Reason |
Company |
| 26-Dec-2023 | Hospira | 4.2% Sodium bicarbonate injection, 8.4% Sodium bicarbonate injection, Atropine sulfate injection | Drugs | Presence of Glass Particulate Matter | Hospira, Inc. |
Date |
Brand Name(s) |
Description |
Type |
Reason |
Company |
| 22-Dec-2023 | Americaine | Benzocaine Topical Anesthetic Spray | Drugs | Presence of benzene | Insight Pharmaceuticals |
| 22-Dec-2023 | No Brand | Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial | Drugs | Presence of Glass Particulate Matter | Hospira, Inc. |
Date |
Brand Name(s) |
Description |
Type |
Reason |
Company |
| 21-Dec-2023 | ResMed | Masks with magnets | Medical Devices | Potential for magnetic interference near certain implants and medical devices | ResMed |
Date |
Brand Name(s) |
Description |
Type |
Reason |
Company |
| 20-Dec-2023 | Busse Hospital Disposals | Medical Device Kits and Trays | Medical Devices | Device & Drug Safety – Potential Lack of Sterility | Busse Hospital Disposals |
| 20-Dec-2023 | Medline | Tracheostomy Care and Cleaning Trays | Medical Devices | Device & Drug Safety – Potential Component Defect | Medline Industries, LP |
Date |
Brand Name(s) |
Description |
Type |
Reason |
Company |
| 18-Dec-2023 | No Brand | Vigabatrin for Oral Solution, USP 500mg | Drugs | Due to seal integrity issues allowing for powder leakage from the pouch. | InvaGen Pharmaceuticals Inc. |
Date |
Brand Name(s) |
Description |
Type |
Reason |
Company |
| 7-Dec-2023 | Covidien and Cardinal Health | Urology and OR room specific kits and trays | Medical Devices | Potential lack of sterility assurance which could result in non-sterile product | Cardinal Health |
Date |
Brand Name(s) |
Description |
Type |
Reason |
Company |
| 30-Nov-2023 | Baxter | Novum IQ syringe infusion pump. | Medical Devices | Potential for an incomplete infusion following one or more downstream occlusion alarms. | Baxter International, Inc. |