Appears as a global challenge for recall of product containing NDMA

1. N D M A
N-NitrosoDiMethylAmine
Probable Cancer Causing Agent
Karachi- 18 July 2018

2. N D M A
N-NitrosoDiMethylAmine
Zhejiang Huahi
Pharmaceuticals, China
Valsartan
A Global Recall due to an
unexpected impurity NDMA

3. Valsartan NDMA

4. What it is
? Yellow Odorless liquid
It was used to make rocket fuel
Unintentionally formed in air,
water, soil during various
manufacturing reactions
involving alkyl amines
Alkyl Amine
Widely distributed throughout
the environment

5. What it is
?
NDMA
Does not persist in the environment, break
down in sunlight in minutes

6. it enters in the human bodyHow
Breathe ContactEat Drink
Enters Blood & goes to many body organs in
minutes
Metabolize in Liver and leave the body within
24 hours through Lungs & Urine
?
?

7. Eating
Drinking

8. it affects human healthHow ?
Evidence of Liver, Lung Cancer & Cell Damages are
established in animals

9. Presence of NDMA can be
detected in blood & urine but
cannot be used to predict
possible health effect

10. <10 ppb of NDMA is
the limit

11. 16 ppm in air per 4
hours cause liver
damage & death in dogs

12. 75 ppm in food for 1
week cause liver
damage in rats

13. 20 ppm in water for 1
day cause liver damage
in hamsters

14. 50 ppm in water for one
week cause death in
mice

15. 50 ppm in food for 5
months cause liver
damage in mice

16. 100 ppm in food for 62
to 93 days cause death
in rats

17. 5.5 ppm in water for 30
weeks cause death in
rats

18. 20 ppm in water for 28
days cause liver damage
in hamsters

19. It's time to create a culture of professionalism by fixing the
trust deficit, not otherwise. Be clear and be aware that
RECALL is the beauty of system and is always healthy.
It's time for every manufacturer to go back and see their
system to ensure that their materials are not containing
NDMA outside the permissible limit. Have you done it? If
you have not conducted test, you must have a valid reason
now to prove that development of NDMA or crossing the
permissible limit in your materials is not possible.
It is the way the SCIENCE speaks and responds. Nothing
more, nothing less.
Nothing
to
Panic
ROOA

20. ROOA-0718-2
Thanks
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