"Increased Surveillance Of Bulk Ingredients Susceptible To Contamination With Diethylene Glycol"

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.

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 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 301 796-5992.


*** Questions related to drug issues may be directed to CDER/Office of Compliance (OC), Imports Exports Compliance Branch. The CDER/OC/Imports Exports Compliance Branch can be contacted at cderimportsexports@fda.hhs.gov***


For questions concerning food or cosmetic issues, contact, of CFSAN's Division of Enforcement.

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

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