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Friday, September 04, 2015
Rx-360 Safety Alert Minimize

Important Alert:  Potentially Adulterated Anti-Foaming Agents

As a result of the events described below, Rx-360 recommends companies check their sources and to investigate their supply chains to prevent potentially adulterated materials to be used in pharmaceuticals.

A letter from a large pharmaceutical company in Hong Kong was sent asking suppliers to answer some questions regarding DEHP (diethylhexyl phthalate) and DINP (diisononyl phthalate).   


From ChinaDialy, June 8, 2011
http://www.chinadaily.com.cn/xinhua/2011-06-08/content_2835890.html

"Taiwan's food and drug department announced that 961 products have been found tainted by toxic plasticizers by Tuesday at noon.

The figure stood at around 500 last Tuesday and increased to 780 on Friday.

The island's health department attributed the increase to the development of the investigation of the clients of two food additive suppliers, which added cancerogenic plasticizers in clouding agents, a food additive widely used in beverages, jelly and jams.

In addition, 280 companies have been involved in the contamination case, up from around 210 companies listed last Tuesday.

In mid May, Taiwan health authorities found food additive supplier Yu Shen Chemical Co. illegally added cancerogenic plasticizer DEHP in clouding agents and sold toxic agents to many food and beverage producers.

Soon another additive supplier, Pin Han Perfumery, was also caught adding another plasticizer DINP in the clouding agents it produced.

As investigators traced the list of the two suppliers' clients, a large number of beverage producers, diet supplement companies, cold drink shops and even five-star hotels were found using tainted products.

The latest clients found by investigators were bakeries. On this weekend, investigators learned that Yu Shen had mixed plasticizer in fruit syrups and sold them to bakeries, which produced fruit-flavored bread and cakes."
 

Their redacted letter is below.

Site Procurement Leader
Subject:  DEHP and DINP Contaminations

Dear Valued Supplier,

Due to a recent incident in Taiwan where DEHP (diethylhexyl phthalate) was substituted for palm oil in the manufacture of emulsifiers for soft drinks, please immediately confirm the following by written response to [Deleted Text]

(1) Are you confident that your supply chain security ensures that your antifoam products are not contaminated with DEHP or DINP (diisononyl phthalate)

(2) Your antifoam ingredients are not supplied by Yu Shen Chemical Company, Pin Han Perfumery Company, or their known distributors.
 

 

  

IPEC Federation Statement Minimize

IPEC Federation: Taiwan Phthalate Contamination Incident
Impact on Safety of Excipients
June 15, 2011 

Recent events in Taiwan have raised the possibility of Di-Ethyl Hexyl Phthalate (DEHP) and Di-isononyl phthalate (DINP) being added to certain nutritional supplements, vitamins, foods and beverages imported from Taiwan. This has resulted in some recalls of certain Taiwanese products. The IPEC Federation has developed this statement and frequently asked questions (FAQs) to address this specific situation in Taiwan.

This issue has raised significant public concern regarding the safety of both raw materials and excipients and pharmaceutical products. IPEC Federation members are using science-based risk management practices to ensure the safety and supply of safe excipient products to customers around the world.

The products of concern were produced with emulsifiers (clouding agents) manufactured by the Yu Shen Chemical Co. or the Pin Han Perfumery Co. that are contaminated with a prohibited ingredient, DEHP and/or DINP .

These chemicals are commonly used as plasticizers for polyvinyl chloride type plastics. While minute quantities of DEHP may be detected in certain food products as a result of migration from plastic containers, the Taiwanese authorities detected DEHP in various beverages at levels up to 600 ppm. It is believed to have been added as a form of Economically Motivated Adulteration as a low-cost replacement for the more expensive palm oil.

There are many other phthalates which are approved for use in pharmaceuticals such as Di-Ethyl Phthalate (DEP) and Di-Butyl Phthalate (DBP). These phthalates can be legally used as plasticizers in drug applications in many countries and they do not pose safety concerns in these applications.

It is important to stress that the Taiwan incident was limited to only DEHP and DINP and the emulsifier products of concern were only produced by the two companies listed above to the best of our knowledge.

At this time, only materials originating from the specifically identified manufacturers in Taiwan are at risk. Drug manufacturers should review their supply chains to determine if they are sourcing emulsifiers that may be implicated in the Taiwanese recalls. To facilitate communication between drug manufacturers and their suppliers the supply chain reviews should focus only on the two phthalates of concern, DEHP and DINP.

Two questions can adequately address the potential risk from the Taiwan incident, as explained in the Rx-360 Alert found on www.rx-360.org. The following questions should form the basis for the communications that drug manufacturers should have with their suppliers.

1) Are you confident that your supply chain security measures ensure that your products are not contaminated with DEHP or DINP?
2) Are your ingredients supplied by Yu Shen Chemical Company, Pin Han Perfumery Company, or their known distributors?
 

The IPEC Federation member companies will be monitoring the situation as it develops, and will be taking appropriate actions to comply with all international safety requirements for the safety and purity of excipient substances. Should additional developments occur, the IPEC Federation will update this information accordingly.

Frequently Asked Questions (FAQs)
Based on the scientific evidence available at this time, we have provided answers, which, in our opinion, may address most Frequently Asked Questions

What is the concern with DHEP and DINP?

It is recognized that DEHP can have significant reproductive and other negative health effects associated with chronic exposure. DEHP is also identified as a toxic substance. DINP is not classified as a carcinogen, reproductive, or developmental toxicant, however, is not approved for use as an ingredient in food or drug products as apparently was done in the Taiwan adulteration incident. There are many other phthalates, however, that are allowable in drug products and packaging materials which are not implicated by the incident in Taiwan.

What products are affected?

Emulsifiers or clouding agents from the Yu Shen Chemical Co. or the Pin Han Perfumery Co. and certain vitamins, nutritional supplements, food and beverages, particularly juices, sport and energy beverages and jams, imported from Taiwan. The Taiwan authorities have initiated recalls of certain brands of these products. DEHP-tainted products have been shipped to the United States, mainland China, Hong Kong, the Philippines and Vietnam.

Have the recent recalls in Taiwan affected IPEC member companies’ ability to supply products to customers?

IPEC members are all assessing the risk and taking appropriate actions to ensure a safe and secure supply of excipients so that there will be minimal, if any, supply chain disruptions

Are raw materials, processing aids and excipients from Taiwan safe for use?

All materials from Taiwan should be evaluated to confirm they are not from the affected materials or companies involved in the contamination events

What about the same materials from the surrounding Asian countries?

No other companies have been implicated at this time, but all companies in the supply chain need to confirm there are no materials originating from the identified suppliers in the supply chain.

Are packaging materials from the affected areas safe? 

Some packaging materials may contain plastics with some phthalate content that has been approved for food contact based on migration criteria. These are not affected.

What kind of testing can be done to ensure no contamination with phthalates has occurred?

Analytical testing can be done to screen for multiple phthalates. This type of testing should only be necessary if chemicals from the identified sources are specifically involved. General testing for phthalates should not be required due to this incident.

  

Additional DEHP Regulatroy Information Minimize

Hong Kong

Warning not to use flavoring agents and syrups from doubtful sources

 

Hong Kong Warning

Phillipinies

List of potentially impacted products.

List of Implicated Products
   

 

  

Updated DEHP Information Minimize

From the US FDA
DEHP in Plastic Medical Devices
http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ChoosingaMedicalDevice/ucm142643.htm

  • What is DEHP and how is it used?

  • Why are there health concerns regarding DEHP?

  • Is there evidence that these effects occur in humans?

  • If these effects occur in humans, which patients would be at most risk?

  • What has been done to date to assess the potential risk?

  • What can be done to reduce the level of DEHP exposure?

     What is DEHP and how is it used?

    DEHP, also known as di-(2-ethylhexyl)phthalate, is a compound used as a plasticizer (softener) in many products made of polyvinyl chloride (PVC) plastic, including some medical devices. Among these are:

    IV bags and tubing

    Umbilical artery catheters

    Peritoneal dialysis bags and tubing

    Tubing used during Hemodialysis

    Blood bags and tubing

    Heart bypass machine tubing

    Nasogastric feeding tubes

    Respiratory tubing

    Enteral nutrition feeding bags


    Why are there health concerns regarding DEHP?

    Exposure to DEHP has produced a range of adverse effects in experimental animals, but those of greatest concern involve effects on the development of the testicles and the production of normal sperm in young animals.


    Is there evidence that these effects occur in humans?

    It is possible that the effects observed in animal studies could occur in humans. However, there are no human studies to date that show such effects. DEHP-containing devices have been used on newborn babies for many years without apparent ill effects, although studies have not been conducted which would rule out effects on humans.


    If these effects occur in humans, which patients would be at most risk?

    The FDA believes the greatest concern would be for very young male infants who are critically ill and have prolonged exposure to multiple devices containing DEHP. Also at risk would be the male fetus, through exposure of his mother, and peripubertal males. The National Toxicology Program, a component of the National Institutes of Health, has recently reached a similar conclusion. In contrast, there is little concern for adults receiving intravenous solutions or undergoing peritoneal
    dialysis.


    What has been done to date to assess the potential risk?

    We have examined the potential risks posed by patient exposure to DEHP by comparing the doses of this compound that patients may receive to a Tolerable Intake (TI) value for DEHP. A TI value is the dose of a compound that is not expected to produce adverse effects in exposed patients. For more information on how the safety assessment for DEHP was performed, as well as the potential risks of exposure to DEHP from various procedures, see the document "Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices1".


    What can be done to reduce the level of DEHP exposure?

    We have issued a Public Health Notification to the medical community, identifying procedures that could result in exposure to relatively high levels of DEHP in sensitive patients (e.g., male neonates). We have recommended that devices made of alternative materials, or that are made of PVC that does not contain DEHP, be used for these procedures. If PVC devices containing DEHP must be used, we recommend that steps be taken to minimize the exposure, e.g., by using the freshest, coldest blood products available, or by using heparin-coated blood tubing.

    We must emphasize that the risks of DEHP exposure are far less than the risks of forgoing critical procedures.

    We will continue to make new information available on this website.

    Link to: FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP2

 

  

 

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