Recent FDA Medication Recalls and Compliance

PDF Version of DQA 08-020 (PDF, 32 KB)

Date:   June 11, 2008 -- DQA Memo 08-020

To:       Adult Day Care  ADC 03
           Adult Family Homes AFH 09
           Ambulatory Surgery Centers ASC 05
           Certified Mental Health and AODA  CMHA 04
           Community Based Residential Facilities CBRF 09
           End Stage Renewal Dialysis ESRD 03
           Facilities for the Developmentally Disabled (FDD)
           FDD 09
           Home Health Agencies HHA 07
           Hospices HSPC 09
           Hospitals HOSP 11
           Nurse Aide Training Programs NATP 04
           Nursing Homes NH 14
           Outpatient Rehabilitation Agencies OPT/SP 03
           Residential Care Apartment Complexes RCAC 08
           Rural Health Clinics RHC 04

From:  Otis Woods, Administrator
           Division of Quality Assurance

Recent FDA Medication Recalls and Compliance

The Centers for Medicare and Medicaid Services (CMS) has become aware, during facility surveys nationally, of instances where facilities have not been in compliance with various Food and Drug Administration (FDA) recalls.

Recent recalls have included heparin products and Digitex ®. These recalls were due to adverse effects occurring in patients, including deaths. Therefore, facility removal of the recalled products is imperative for patient safety. The FDA information on recalled products and lot numbers may be accessed at the FDA Web site located at http://www.fda.gov/opacom/7alerts.HTML.

Pharmacy providers and distributors and health care providers should be monitoring their supplies, including, for example, crash carts and storage cabinets, and removing recalled products in order to assure that recalled products are not available for patient/resident use.

In response to the recent finding nationally, CMS has asked the state survey agencies to do the following:

• Distribute a list of recalled heparin drugs to surveyors;
• Include a check of the possible presence of these recalled drugs during the course of surveys;
• Request a copy of any facility-written procedures for implementing drug recalls; and
• Request a description of staff notification and education efforts used to ensure that recalled heparin is not used for patient care.

For further information, please contact Doug Englebert at 
(608) 266-5388.

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