IA #55-02 -10/19/07, IMPORT ALERT #55-02, "INCREASED SURVEILLANCE OF GLYCERIN
DUE TO THE PRESENCE OF DIETHYLENE GLYCOL"
This alert is being revised to provide updated information for continued
surveillance sampling of bulk glycerin shipments and to add new product codes.
Changes are bracketed by 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: 45N[][]99 - Formulation aid
45Q[][]99 - Humectant, food use
46D[][]99 - Solvent, food use
*** 46Y[][][] - Food additives for human use ***
53P[][]99 - Cosmetic raw material
55Q[][]16 - Humectant, pharmaceutical necessity
55Q[][]58 - Solvent, pharmaceutical necessity
64H[][]04 - Iodinated Glycerol (expectorant)
*** 55Q[][]07 - Pharm Nec (Mfr)/Sorbitol Pharmaceutic
Necessity Flavor) ***
*** 55R[][]45 - Pharm Nec (Mfr)/ Sorbitol (Pharmaceutical
Necessity Tablet Excipient) ***
*** 55Q[][]64 - Pharm Nec (Mfr)/ Propylene Glycol
(Pharmaceutical Necessity Solvent) ***
*** 55P[][]68 - Pharm Nec (Mfr)/ Propylene Glycol
Monostearate (Pharmaceutical Necessity
Emulsifying Agent) ***
PROBLEM: Contamination with diethylene glycol
COUNTRY: ALL (ZZ)
MANUFACTURER/
SHIPPER: N/A
PAC: 56008H - drugs
PAF: DRA (Drug ingredient analysis)
CHARGE: The charge will depend upon the type of product:
For a drug/USP grade product, 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: Division of Import Operations and Policy (HFC-170)
REASON FOR
ALERT: In October 2006, a number of illnesses and deaths in Panama
were linked to cough syrup that was found to be contaminated
with diethylene glycol (DEG). Laboratory analysis performed
by the U.S. Centers for Disease Control (CDC), which were
subsequently confirmed by the Forensic Chemistry Center,
detected DEG, an ingredient in anti-freeze products, in two
samples of acetaminophen elixir products, "Afebril" and
"Valodon." The source of the contamination was determined
to be glycerin that had been adulterated with less expensive
but highly toxic DEG and shipping records indicate the
source of the glycerin may have been China.
More recently, toothpaste manufactured in China was removed
from stores in Panama, the Dominican Republic, and Australia
after the products were determined to contain DEG. Multiple
other incidents involving pharmaceutical products made with
DEG contaminated glycerin have occurred including an
incident in 1996 involving acetaminophen syrup that was
linked to the deaths of 80 children in Haiti. In 1937, over
100 people in the United States died of renal failure after
consuming an elixir marketed to treat infections that was
prepared with DEG. Glycols, such as glycerin, are present
in many formulations of medicinal, as well as cosmetic and
food products. OASIS entry data indicates that
approximately 1000 shipments of bulk glycerin/glycerol are
received in the United States per year. Bulk
glycerin/glycerol was received from 21 different countries
with the majority originating from Malaysia, Indonesia,
France, Germany, India, and the Philippines.
GUIDANCE: Increased surveillance of imported glycerin in either Bulk
or retail units, from any country, including those which are
identified for industrial use, is indicated. Appropriate
OASIS screening has been set. As part of the priority
review process, import entry documents should be requested
to verify the country of production, the manufacturer of the
product, and any evidence of transshipment. Discrepancies
should be noted and OASIS entry data should be updated.
The following guidelines should be used in determining when
a sample should be collected:
All shipments manufactured, originating, or transshipped
through China should be sampled.
All shipments that have been transshipped through countries
other than the country of manufacture should be sampled;
Shipments not transshipped and not from China should be
sampled from as many different manufacturers and countries
as possible. Districts should contact DIOP before sampling.
The DIOP contacts are:
Ted Poplawski (Ted.Poplawski@FDA.HHS.GOV) at 301-594-3849
John E. Verbeten (John.Verbeten@FDA.HHS.GOV) at
301-594-3853.
All samples should be collected in import status. Collect a
minimum of three one-pint sub-samples from three different
units selected at random. If the shipment consists of
multiple lots, collect three one-pint sub samples from each
lot.
Additional questions should be directed to the DIOP
contacts.
A composite should be compared from all sub samples
collected from a specific lot of glycerin. The composite
should be analyzed by the Gas Chromatographic screening
method for diethylene glycol in glycerin under LIB# 4042
with adjustments to chromatographic conditions as necessary.
Since this is a screening procedure, spike recovered and
duplicate analyses are not necessary.
Analysis has been arranged as follows:
Region Laboratory Weekly Lab
Capacity
Northeast NRL 25
Central NRL See above
Southeast SJN 15
Southwest DEN 5
Pacific (CA, AZ) PRL-SW 20
Pacific (WA, OR) PRL-NW 10
Sample analysis should be completed within three working
days from the receipt of the sample. Servicing laboratories
will be provided a report form and instructions for the
completion and submission of the sample status report.
For questions or issues concerning science, science policy,
sample analysis, preparation or analytical methodology, or
the sample report form, contact Thomas Savage
(Thomas.Savage@FDA.HHS.GOV) at 301-827-1026.
Questions concerning drug issues should be directed to Edwin
Rivera-Martinez at (301) 827-9012 or John Dietrick at
(301)827- 9021 of CDER's Division of Manufacturing and
Product Quality (HFD-320).
FOI: No purging required
KEYWORDS: Glycerin, diethylene glycol
PREPARED BY: Nawab Siddiqui, DIOP, (301) 594-3871
DATE LOADED
INTO FAIRS: October 19, 2007
Under the Authority of
Domenic Veneziano, CDR USPHS
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