FDA

In a letter to MIDMARK, The FDA has cited a number of violations in the production of the M-11 Autoclave. This is a device that is in use in the offices of many doctors in private practice across the country. Most of the violations related to failure to keep adequate records of production of these Autoclaves. One specific item referenced involved failure to provide a timely report of a malfunction where the door of the autoclave blew off. The FDA letter states that this "would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur"

Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria
including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab)

AUDIENCE: Rheumatology, Gastroenterology, Oncology

Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms

AUDIENCE: Oncology, Anesthesiology

Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error
includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, Tri-Previfem

AUDIENCE: Consumer, Pharmacy, OB/GYN

Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions

AUDIENCE: Psychiatry, Patients

Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment

AUDIENCE: Endocrinology, Pharmacy, Patient

H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing
Multiple brands affected

AUDIENCE: Pharmacy, Consumer, Risk Manager

Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency

AUDIENCE: Risk Manager, Pharmacy

Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects

AUDIENCE: OBGYN, Pharmacy, Infectious Disease

Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

AUDIENCE: Infectious Disease, Psychiatry, Family Practice