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