| Alyglo (immune globulin intravenous, human-stwk) |
Increased hypersensitivity reactions in patients receiving certain product lots |
FDA is evaluating the need for regulatory action. |
|
Bispecific T-cell engager therapies
- Columvi (glofitamab-gxbm) injection
- Epkinly (epcoritamab-bysp) injection
- Imdelltra (tarlatamab-dlle) for injection
- Kimmtrak (tebentafusp-tebn) injection
- Talvey (talquetamab-tgvs) injection
|
Hypogammaglobulinemia |
FDA is evaluating the need for regulatory action. |
|
Briumvi (ublituximab-xiiy) injection
Kesimpta (ofatumumab) injection
Mavenclad (cladribine) tablets
|
Colitis |
FDA is evaluating the need for regulatory action. |
| Calquence (acalabrutinib) capsules; tablets |
Aplastic anemia |
FDA is evaluating the need for regulatory action. |
| Datroway (datopotamab deruxtecan-dlnk) for injection |
Infusion related reaction, including anaphylaxis |
FDA is evaluating the need for regulatory action. |
| Gavreto (pralsetinib) capsules |
Hepatitis B reactivation |
FDA is evaluating the need for regulatory action. |
| Gavreto (pralsetinib) capsules |
Rhabdomyolysis |
FDA is evaluating the need for regulatory action. |
| Gavreto (pralsetinib) capsules |
Tuberculosis |
FDA is evaluating the need for regulatory action. |
| Metformin-containing products |
Lactic acidosis in patients with mitochondrial disease |
FDA is evaluating the need for regulatory action. |
| Vecuronium bromide injection (a particular generic product) |
Product label confusion |
The peel-off sticker on the container label was revised to include all required information, including the total quantity of drug substance per total volume and the expression of strength as 1 mg/mL concentration after reconstitution.
|
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