Ranigast

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

The presence of N-nitrosodimethylamine (NDMA) contamination was found in the active substance ranitidine used to manufacture the Ranigast 150 mg, film-coated tablet batches, which constitutes a quality defect of the medicinal product. Potential effects: increased risk of carcinogenic effects and toxic liver damage.

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Risk Level

Critical

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Batch Number

41116, 21116, 31116, 71116, 81116, 51116, 61116, 90117, 30117, 130117, 120117, 110117, 80117, 70117, 100117, 80317, 60517, 50317, 40317, 30317, 100347, 70317, 120317, 110317, 90317, 50417, 60417, 80417, 90417, 70417, 10717, 70717, 30717, 20717, 40717, 50717, 60717, 80717, 70917, 30917, 40917, 60917, 50917, 171017, 121017, 111017, 81017, 131017, 161017, 151017, 141017, 181017, 191017, 101017, 41117, 61117, 51117, 21117, 71217, 11217, 31217, 21217, 41217, 51217, 61217, 111217, 101217, 60218, 90218, 30218, 20218, 10218, 50218, 70218, 80218, 40218, 10418, 20418, 40418, 30418, 40618, 30618, 20618, 70818, 80818, 10818, 40818, 20818, 50818, 60818, 40918, 20918, 30918, 11018, 21016, 31018, 101018, 111018, 31118, 21118, 41118, 11118, 81118, 71118, 61118, 11218, 21218, 31218, 40119, 100119, 50119, 60119, 80119, 70119, 70219, 60219, 20319, 10319, 30319, 10419, 40519, 30519, 10519, 50519, 30619, 20519, 10619, 20619, 50819, 60819

Notice Date

28.10.2019

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use Ranigast from the listed batches; if you have any packs, return them to a pharmacy and discuss further treatment with your doctor.

Actions Taken

The Chief Pharmaceutical Inspector withdrew from the market nationwide all listed batches of Ranigast 150 mg, film-coated tablets, following a request from the marketing authorisation holder and confi...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Ranigast

What to do if you have this product?

What You Should Know

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