CAPS Announces Voluntary Recall of Injectable Products Manufactured at Lanham, Maryland Facility.LANHAM, Md. -- Summary of Events and Steps to Protect Patient Safety --FDA reported on September 16, 2005 to CAPS that specific formulations of cardioplegia solutions manufactured in CAPS Lanham, Maryland Lanham is an unincorporated community in Prince George's County in the State of Maryland in the United States of America. Because it is not formally incorporated, it has no official boundaries, but the United States Census Bureau has defined a census-designated place consisting of facility contained bacteria. Placing patient-safety as company priority led to the decision by CAPS to immediately include all injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. products manufactured at Lanham, Maryland in a recall advisory --Each CAPS solution is individually manufactured according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. physician specifications --CAPS initiated an immediate voluntary recall of injectable products distributed to Maryland, Delaware, Washington, DC, and Virginia customers --All 46 Lanham Maryland customers were advised immediately to quarantine quarantine (kwŏr`əntēn), isolation of persons, animals, places, and effects that carry or are suspected of harboring communicable disease. these products as a precaution --CAPS is working with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to determine the source of the bacteria --This voluntary recall does not affect other CAPS facilities On Friday, September 16, 2005, the Central Admixture Pharmacy Services (CAPS) facility at Lanham, Maryland voluntarily recalled injectable products manufactured at the facility through September 16th. All customers were immediately advised of the voluntary recall, and asked to quarantine all Lanham-manufactured injectable products. The CAPS facility in Lanham, Maryland distributed injectable products to a total of 46 hospitals and home-care services in Maryland, Delaware, Washington, DC and Virginia only. The voluntary recall was initiated after Food and Drug Administration (FDA) testing identified bacteria classified as gram negative rods in specific formulations of cardioplegia solutions manufactured at the Lanham, Maryland CAPS facility. Immediately acting on this information, CAPS voluntarily recalled all injectable products manufactured at this site in order to ensure patient safety. As a precaution, the company has also suspended production at the Lanham facility while it works with the FDA to determine the source of the bacteria. These tests will require at least 2 weeks. CAPS facilities adhere to adhere to verb 1. follow, keep, maintain, respect, observe, be true, fulfil, obey, heed, keep to, abide by, be loyal, mind, be constant, be faithful 2. the procedures and processes described in United States Pharmacopeia United States Pharmacopeia /Unit·ed States Phar·ma·co·peia/ (USP) a legally recognized compendium of standards for drugs, published by The United States Pharmacopeial Convention, Inc., and revised periodically. chapter 797, "Pharmaceutical Compounding--Sterile Preparations." USP USP - unique sales point 797 is the standard for pharmacies to follow when making injectable preparations. No other CAPS facility or customer healthcare facility outside this region is impacted by this voluntary recall. All other 18 CAPS facilities nationwide are operating as usual. CAPS will issue updates as more information becomes available. |
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