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.

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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