Page 152 - PENARIKAN PRODUK RANITIDIN YANG TERKONTAMINASI N-NITROSODIMETHYLAMINE (NDMA)

Judul : BPOM Suspends Production and Distribution of Ranitidine,
Orders Recall

Nama Media : jakartaglobe.id

Tanggal : 11 Oktober 2019
Halaman/URL: https://jakartaglobe.id/context/bpom-suspends-production-and-
distribution-of-ranitidine-orders-recall

Tipe Media : Online

Jakarta. The National Drug and
Food Control Agency, or BPOM,
announced on Friday that it had
ordered the suspension of
production and sales and a recall of
all products containing ranitidine,
following a report of possible
contamination that may cause
cancer.
Ranitidine is commonly found in
medication used to treat peptic and
gastric ulcers.

The action is based on a warning by the United States Food and Drug Administration
and European Medicine Agency on Sept. 13 that small amounts of
nitrosodimethylamine (NDMA) had been discovered in a sample of ranitidine products.

BPOM head Penny Lukito said studies have determined that the safe level of NDMA
intake is 96 nanograms per day.

"There's risk of a carcinogenic effect if consumed long-term, based on the study. If not
used long-term, the carcinogenic effect should be absent," Penny said.

The agency ordered pharmaceutical firms licensed to produce medicines that may
contain more than the acceptable level of NDMA to stop production and distribution
and to recall distributed products.
In Indonesia, ranitidine can be found in Zantac and Rinadin, among others.

"On Oct. 9, the BPOM found that there were many ranitidine products exceeding safe
levels of NDMA. We decided to order pharmaceutical companies holding licenses for
ranitidine products to stop all production and distribution," Penny said.

The BPOM continues to test samples of ranitidine products, but Penny said no
deadline had been set for the completion of the process.

"[The tests] will take time. There are 67 ranitidine products in total in Indonesia. From
the 10 samples we have tested, six were confirmed positive," she said, adding that the
suspension was temporary until a more comprehensive study could be undertaken.

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