IA #55-02, 12/19/08, IMPORT ALERT #55-02, "INCREASED SURVEILLANCE OF *** BULK
INGREDIENTS SUSCEPTIBLE TO CONTAMINATION WITH *** DIETHYLENE GLYCOL"
*** Revision to this import alert dated 12/19/2008 broadens the scope of the
alert to include other products susceptible to contamination with diethylene
glycol. Changes are bracketed by asterisks ***
Previous revision of this import alert, dated 10/19/2007, provided updated
information for continued surveillance sampling of bulk glycerin shipments and
added new product codes.
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; *** Propane-1,2,3-triol;
1,2,3-propanetriol; 1,2,3-trihydroxypropane; Glyceritol;
Glycyl alcohol; Incorporation Factor ***
*** Propylene Glycol (PG) aka Propane-1,2-diol; 1,2-
propanediol; 1,2-Dihydroxypropane, Monopropylene glycol;
Methyl ethyl glycol (MEG); Methylethylene glycol, Sirlene,
Dowfrost***
*** Sorbitol aka Glucitol; (2S, 3R, 4R, 5R)-Hexane-
1,2,3,4,5,6-hexol; D-glucitol; D-sorbitol; L-gulitol;
Sorbit***
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
PAF: *** DRT (Drug Testing) ***
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), subsequently
confirmed by FDA's 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; shipping records indicated the source of the
glycerin may have been China.
*** In 2007, *** 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 a DEG contaminated elixir marketed to treat
infections.
*** In 2008, teething relief products were removed from the
market in Nigeria after the deaths of over 40 children in
that country. The product of concern, a combination of an
analgesic and an antihistamine, was determined to have been
contaminated with DEG. The DEG contamination is believed to
have come from contaminated propylene glycol. ***
Glycols, such as glycerin ***, propylene glycol and sorbitol
***, are present in many formulations of medicinal, food,
and cosmetic products. OASIS entry data indicates that
approximately 1100 shipments of bulk glycols are received in
the United States per year.
GUIDANCE: Increased surveillance of imported glycerin ***, propylene
glycol and sorbitol *** from any country 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:
Only fluid products are indicated for sampling.
All shipments manufactured, originating from, or
transshipped through China are indicated for sampling.
All shipments that have been transshipped through countries
other than the country of manufacture are indicated for
sampling.
Shipments not transshipped and not manufactured/originating
from China should be sampled from as many different
manufacturers and countries as possible, as District
resources permit. ***
All samples should be collected in import status. Collect a
minimum of three (3) one-pint sub-samples from three (3)
different units selected at random. If the shipment
consists of multiple lots, collect three (3) one-pint sub
samples from each lot.
*** Indicate in the collection report, "Analyze for DEG" ***
*** If a sample collected under this Import Alert is found
to contain diethylene glycol (DEG), Districts should
immediately contact DIOP. ***
*** For additional questions or issues concerning operations
or regulatory policy, contact Andrew J. Seaborn, at (301)
443-6553, of the Division of Import Operations and Policy.
***
*** For questions or issues concerning science, science
policy, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 827-7605. ***
For questions concerning drug issues, contact Edwin Rivera-
Martinez of CDER's Division of Manufacturing and Product
Quality at (301) 796-3274, or *** Anthony Lee of CDER's
Import/Export Team at (301) 796-3319 ***.
*** For questions concerning food or cosmetic issues,
contact Felicia Binion Williams, at (301) 436-2566, of
CFSAN's Division of Enforcement. ***
FOI: No purging required
KEYWORDS: Glycerin, diethylene glycol, *** propylene glycol, sorbitol
***
ORIGINAL
ISSUE DATE: 8/1/1996
ORIGINAL
PREPARED BY: Fredda Shere-Valenti, DIOP, 8/1/1996
REVISED BY: Andrew J. Seaborn, DIOP, 12/19/2008
Nawab Siddiqui, DIOP, 10/19/2007
DATE LOADED
INTO FAIRS: December 19, 2008
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