Recent FDA Medication Recalls and Compliance
PDF Version of DQA 08-020
(PDF, 32 KB)
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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