June 2017

FDA Med Watch: Clindamycin Injection ADD - Vantage Vials by Alvogen - Recall: Lack of Sterility Assurance

Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.

CMS Memo: REVISED ESRD Facilities - Filling Saline Syringes at the Patient Treatment Station

The 2008 ESRD Conditions for Coverage at 42 CFR 494.30(b)(2) state that the facility must "ensure that the clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications…"

Dialysis procedures for initiation and discontinuation of hemodialysis treatments require the use of sterile normal saline in syringes to aid in the care of a patient’s vascular access. During survey observations, ESRD facilities have been noted to fill syringes with saline for vascular access care or to flush medications by drawing saline from the single dose saline bag or the IV tubing connected to the patient at the dialysis station.

CMS Memo: ESRD Facilities - Cleaning the Patient Station

Dialysis facilities are traditionally configured with individual treatment bays, called dialysis "stations," where patients receive their in-center dialysis treatments. Dialysis stations contain a patient chair or bed and the dialysis delivery equipment. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses.