Medicines withdrawn from the market in Poland (CURRENT LIST)

The Main Pharmaceutical Inspectorate ordered the withdrawal from pharmacies across Poland of two series of the drug used in erectile dysfunction Tadalafil Aristo. According to the GIF, it cannot be ruled out that the product “may pose a risk to the health of the patient”. Tadalafil Aristo is another drug withdrawn by GIF recently.

1. GIF withdraws from the market drugs whose tests have revealed, for example, a quality defect or misleading markings
2. The latest GIF announces the recall of two series of the drug used in erectile dysfunction Tadalafil Aristo
3. Earlier, the sale of, among others, Structum, Angusta drugs, Lactulose-MIP, Sumilar
4. If you have a medicine in your home medicine cabinet with the same name as the one withdrawn from the market, check its batch and expiry date. If it is the same as decided, do not use it anymore and recycle it
5. More information can be found on the TvoiLokony home page    

The drug for erectile dysfunction Tadalafil Aristo withdrawn from pharmacies

On July 12, the Main Pharmaceutical Inspectorate ordered the withdrawal of two series of the drug used in erectile dysfunction Tadalafil Aristo from pharmacies throughout Poland. The withdrawn series are:

Tadalafil Aristo (Tadalafilum), 5 mg, film-coated tablets, batch number: 1464005K expiry date: 30.04.2024/XNUMX/XNUMX

Tadalafil Aristo (Tadalafilum), 20 mg, coated tablets, batch number: 1462014C, expiry date: 31.05.2024/XNUMX/XNUMX, MAH: Aristo Pharma Sp. z o. o. with its seat in Warsaw.

The reason is “non-compliance with good manufacturing practices by one of the manufacturers of the medicinal product”, which resulted in the suspension of the GMP (Good Manufacturing Practices) certificate. Moreover, the MAH notification was supported by the opinion of the manufacturer / importer, Aristo Pharma GmbH, who recommended a batch recall of Tadalafil Aristo.

“In view of the above, it should have been deemed to be sufficiently substantiated that it cannot be ruled out that leaving the medicinal product in question on the market may pose a threat to the patient’s health” – informs the Main Pharmaceutical Inspectorate.

The inspector’s decision is immediately enforceable.

Structum drug withdrawn from pharmacies

At the beginning of July, the Main Pharmaceutical Inspector withdrew the drug Structum from the market throughout the country. Three series have been retired:

1. batch number: G20076, expiry date: 31.10.2024/XNUMX/XNUMX
2. batch number: G20077, expiry date: 30.11.2024/XNUMX/XNUMX
3. batch number: G20078, expiry date: 30.11.2024/XNUMX/XNUMX

“The Chief Pharmaceutical Inspectorate received information from the authorized representative of the MAH about the quality defect and the need to recall several batches of this drug, for which the results of the TAMC parameter (total number of aerobic bacteria) were out of specification and the presence or probability of Bacillus cereus was demonstrated,” explains GIF.

The series of tablets Angusta 25 mcg withdrawn from the market

The Main Pharmaceutical Inspectorate ordered the withdrawal from pharmacies throughout Poland of a series of the drug facilitating the onset of labor. These are Angusta 25 mcg tablets, 8 tablets, batch number: B26789, expiry date: 30.09.2023/XNUMX/XNUMX.

The decision is immediately enforceable.

Marketing authorization holder: Norgine BV based in the Netherlands.

Lactulose-MIP syrup withdrawn from the market

On June 13, the Main Pharmaceutical Inspectorate ordered the withdrawal of a series of the drug for constipation from pharmacies throughout Poland. It’s about Lactulose-MIP syrup. The decision is immediately enforceable.

By Decision No 13, the product batches with the following numbers and expiry dates were withdrawn from the market:

batch number: 2900301 expiry date: 09.2024

batch number: 2900401 expiry date: 09.2024

batch number: 2900601 expiry date: 09.2024

batch number: 2901501 expiry date: 09.2024

batch number: 2901601 expiry date: 11.2024

batch number: 2901701 expiry date: 11.2024

batch number: 2901801 expiry date: 11.2024

Marketing Authorization Holder: MIP Pharma Polska Sp. z o. o., ul. Orzechowa 5, 80-175 Gdańsk

By decision No. 14, GIS recalled Lactulose-MIP syrup, 9,75 g / 15 ml, batch number: 3139208, expiry date: 09.2024. The responsible entity in the exporting country is MIP Pharma Austria GmbH (parallel importer: InPharm Sp. Z oo).

The reason for the issued decisions is a quality defect: the risk of microbiological contamination of the active substance used to manufacture the medicinal product.

Sumilar HCT suspended from trading

At the beginning of May, the Main Pharmaceutical Inspector issued a decision to suspend a series of prescription drugs from trading all over the country Sumilar HCT. Responsible entity is Sandoz GmbH.

The drug is used for treatment high blood pressure.

The reason for the decision is the suspicion of a quality defect, «due to the identification of abnormal color appearance inside the blister pack«.

The product batch with the batch number has been suspended from the market 12574261

Accupro withdrawn from pharmacies

On April 25, the Main Pharmaceutical Inspector withdrew the drugs from the market throughout the country Accupro 5, Accupro 10, Accupro 20 i Accupro 40. The responsible entity is Pfizer Europe MA EEIG based in Belgium. The drug is used to treat essential hypertension and congestive heart failure.

The decision was made in connection with the presence of an impurity (N-Nitroso-quinapril) above the acceptable daily intake limit.

In total, several dozen product series have been withdrawn. You can find their full list here: Hypertension drug withdrawn from pharmacies

Vigantol withdrawn from the market

The Main Pharmaceutical Inspector withdrew the medicinal product from the market throughout the country Vigantol at a strength of 500 mcg / ml (20 IU / ml).

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The packaging of Vigantol with serial number was withdrawn 20CQ046. The basis for the withdrawal was an out-of-specification result for the parameter of active substance content.

Responsible entity is P&G Health Germany GmbH.

Vigantol drops are used to prevent rickets in premature babies, children and adults, and osteomalacia in children and adults. In addition, this drug is indicated for the prevention of vitamin D deficiency and diseases associated with the risk of vitamin D deficiency in children and adults, and as an adjunct to osteoporosis in adults.

Glycerin withdrawn from the market

The Main Pharmaceutical Inspector decided to withdraw the pharmaceutical raw material – glycerin 85% from the market throughout the country. The entity responsible is Zakład Farmaceutyczny Amara Sp. z o. o

The reason for the recall is a quality defect «The MAH informed the Main Pharmaceutical Inspector about receiving out-of-specification results for the parameter: sugars. The research was carried out on reference samples of pharmaceutical raw material as part of the complaint procedure »- informs GIF.

A total of 20 product series were recalled. You can find the exact list here: A popular product is disappearing from pharmacies. Guilty quality defect

Atorvox withdrawn from the market

At the end of March, the Main Pharmaceutical Inspector decided to withdraw a medicinal product called Atorvox from the market.

Atorvox is a medicine that contains the active substance atorvastatin (Atorvastatinum). The indication for its use is an increased level of serum cholesterol. It is used to lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, especially when diet and other non-pharmacological treatments have not worked well.

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The rationale for the decision is an error in the indication of the strength of the medicinal product on the outer packaging.

«The President of the Office [Registration of Medicinal Products, Medical Devices and Biocidal Products – ed.] Indicated that the current graphic design of the outer packaging of the above-mentioned The medicinal product contains the correct information on the strength of the medicinal product, i.e. 40 mg, on three sides of the outer packaging, and at the same time incorrect information on the strength of 20 mg, on one of the side walls of the packaging. Described above an error on the outer packaging may lead to incorrect dispensing of the medicinal product from the pharmacy, which, in the opinion of the President of the Office, may pose a threat to public health and constitutes a premise for the withdrawal of the mislabeled medicinal product from the market ”- reported GIF.

The GIF decision concerns a specific (one) product series:

1. Atorvox (Atorvastatinum) 40 mg, film-coated tablets, batch number: 21212 expiration date: 09.2023

The rest of the text below the video.

Vigantol and APAP withdrawn from the market

W March 2022 r. GIF made two other product recall decisions medicinal.

The first was the document on the drug Vigantol, containing 500 µg of cholecalciferol (corresponding to 20 IU of vitamin D000). This product, thanks to its convenient form (oral drops), and a low dose it is given primarily to children, including infants and premature babies. The reason for the withdrawal of the drug was a quality defect. In the course of the tests, it was found that the parameters of the content of the active substance are out of specification. The decision concerned the packaging of Vigantol, series 19KQ193, with the expiry date of 10.2024.

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The second drug withdrawn this month was APAP Intense – a popular product combining paracetamol and ibuprofen with anti-inflammatory and analgesic properties. It was a drug containing Ibuprofenum and Paracetamolum in a dose of 200 mg + 500 mg, series P2009118, expiry date 06.2023. This product has also been discontinued due to a quality defect. It consisted in the fact that the drug sample did not meet the requirements specified in the product documentation regarding the appearance parameter.

What to do with the recalled medicine that we have at home?

If you have a recall medicine in your medicine cabinet, first check its series and expiration date. It may turn out that you bought the same product, but with a different series and validity, and no objections were found to this batch.

However, if the lot number and the expiry date match, the drug is not suitable for use. Remember that medicinal products should not be thrown away in the normal bina, because the substances they contain are a threat to the natural environment (they destroy soil and water, poison plants and animals, and decompose very slowly, even for several dozen years). Instead, take them to the pharmacy at the earliest opportunity, where there are special containers for expired or withdrawn medicationswhich are then sent for disposal at special points.

It may happen that the recalled drug is a product that you take constantly. In this case, stop taking it immediately and contact your doctor or general practitioner who will prescribe a replacement immediately.

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