IA #55-02 - 1/29/02, IMPORT ALERT #55-02, "INCREASED SURVEILLANCE OF GLYCERIN DUE TO THE PRESENCE OF DIETHYLENE GLYCOL" This alert is being revised to reflect an easier scientific method to screen diethylene glycol in glycerin. The guidance section has been revised to reflect this by use of asterisks (***). TYPE OF ALERT: INCREASED SURVEILLANCE (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer rights for or on any person, and does not operate to bind FDA or the public.) PRODUCT: Glycerin aka Glycerine, Glycerol, 1,2,3-Propanetriol, Trihydroxypropane PRODUCT CODE: 55Q[][]16 55Q[][]58 Lubricant in in-vitro diagnostics Glycerin lozenges Glycerin Suppositories, infant/children/adult PROBLEM: Contamination with diethylene glycol COUNTRY: ALL (ZZ) MANUFACTURER/ SHIPPER: N/A PA: 56008H PAF: HAZ CHARGE: The charge will depend upon the type of product: For a drug or device, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health [Adulteration, 501(a)(2)(A)]" OASIS CHARGE CODE: INSANITARY RECOMMENDING OFFICE: CDER/Division of Manufacturing and Product Quality (HFD-320) Division of Import Operations and Policy (HFC-170) REASON FOR ALERT: On June 25, 1996, the Pan American Health Organization (PAHO) issued a press release reporting an epidemic of acute renal failure in Haiti apparently caused by contaminated liquid acetaminophen manufactured in that country. Laboratory analysis performed by the U.S. Centers for Disease Control (CDC) which were subsequently confirmed by FDA analysis, found diethylene glycol, an ingredient of automobile anti-freeze, in two samples of acetaminophen elixir products, "Afebril" and "Valodon." Additional investigation by FDA determined the glycerin used in the production of these medications may have been contaminated with diethylene glycol based on contamination found in glycerin samples collected from the same distributor. Shipping records indicate the original source of the glycerin may have been China. A review of electronic entry data by U.S. Customs Service for calendar year 1996 found no entries of glycerin from China. However, there is a concern that Chinese glycerin may be transshipped through other countries such as Germany or the Netherlands. GUIDANCE: Increased surveillance of all bulk glycerin importations from China, including those which are identified for industrial use, is indicated. Bulk glycerin imported from other sources where there may be a potential for transshipment from China, may also be considered for review. *** There is a concern that the identification test for glycerin in the USP monograph will not verify the presence of diethylene glycol in glycerin or glycerin containing drug products. Therefore, a simple TLC method developed by the Division of Testing and Applied Analytical Development, titled "Simple At-site Detection of Diethylene Glycol/ Ethylene Glycol Contamination of Glycerin and Glycerin-Based Raw Materials by Thin-Layer Chromatography," Kenyon, A.S., et. al., published in the Journal of AOAC International, 81, 44-50 (1998) can be used as a quick screening test. Confirmatory testing, if needed, may be performed by the method developed under LIB #4042, "A Procedure to Determine Diethylene Glycol (2,2'-Oxybisthanol) and Ethylene Glycol (1,2-Ethanediol) in Glycerin and Selected Products," available through the Division of Field Science, (301) 827-7605. *** Questions concerning drug issues should be directed to John Dietrick of CDER's Division of Manufacturing and Product Quality (HFD-320), (301) 594-0095. FOI: No purging of this document is required KEYWORDS: Glycerin, diethylene glycol PREPARED BY: Fredda Shere-Valenti, DIOP, (301) 443-6553 DATE LOADED INTO FIARS: January 29, 2002