Products withdrawn from pharmacies. It is a drug for hypertension and a preparation with vitamin D.

The Main Pharmaceutical Inspector issued a decision on withdrawing from the market four similar drugs nationwide: Accupro 5, Accupro 10, Accupro 20 and Accupro 40, as well as the medicinal product Vigantol.

1. GIF decided to recall the Accupro 5, Accupro 10, Accupro 20 and Accupro 40 drugs. The reason for the recall is contamination above the Acceptable Daily Intake Limit.
2. The drug is used to treat high blood pressure
3. The medicinal product Vigantol has also been withdrawn – these are oral drops containing vitamin D.
4. More information can be found on the Onet homepage

Accupro drugs withdrawn from pharmacies – lot numbers

The Main Pharmaceutical Inspector withdrew the drugs from the market throughout the country Accupro 5, Accupro 10, Accupro 20 i Accupro 40. Responsible entity is Pfizer Europe MA EEIG based in Belgium.

What series have been discontinued?

ACCUPRO 5 (Quinaprilum) 5 mg, film-coated tablets, pack of 30 tablets

1. batch number: FR1997, expiry date: 30.11.2024/XNUMX/XNUMX
2. batch number: FF2033, expiration date: 31.10.2022/XNUMX/XNUMX
3. Lot number: ET1536, expiration date: 31.10.2022/XNUMX/XNUMX
4. batch number: DR4162, expiration date: 31.10.2022/XNUMX/XNUMX
5. batch number: DC1456, expiry date: 30.09.2022/XNUMX/XNUMX

ACCUPRO 10 (Quinaprilum) 10 mg, film-coated tablets, pack of 30 tablets

1. batch number: FN2870, expiration date: 30.06.2023/XNUMX/XNUMX
2. batch number: FJ0419, expiry date: 30.06.2023/XNUMX/XNUMX
3. batch number: FE6831, expiry date: 30.04.2023/XNUMX/XNUMX
4. batch number: EY7391, expiry date: 30.04.2023/XNUMX/XNUMX
5. batch number: EM1556, expiry date: 30.04.2023/XNUMX/XNUMX
6. batch number: EJ7128, expiry date: 30.04.2023/XNUMX/XNUMX
7. batch number: EA0782, expiry date: 30.04.2023/XNUMX/XNUMX
8. batch number: EN8321, expiry date: 30.04.2023/XNUMX/XNUMX
9. batch number: EA0784, expiry date: 30.11.2022/XNUMX/XNUMX
10. batch number: DM5062, expiry date: 30.11.2022/XNUMX/XNUMX

ACCUPRO 20 (Quinaprilum) 20 mg, film-coated tablets, pack of 30 tablets

1. batch number: FM6645, expiry date: 30.06.2023/XNUMX/XNUMX
2. batch number: FM3990, expiry date: 30.06.2023/XNUMX/XNUMX
3. Batch Number: FL1132, Expiration Date: 30.06.2023/XNUMX/XNUMX
4. batch number: FJ1090, expiry date: 30.06.2023/XNUMX/XNUMX
5. batch number: FG9082, expiry date: 30.06.2023/XNUMX/XNUMX
6. batch number: FD9328, expiry date: 30.06.2023/XNUMX/XNUMX
7. batch number: EY3975, expiry date: 30.06.2023/XNUMX/XNUMX
8. Lot number: ET1538, expiration date: 30.04.2023/XNUMX/XNUMX
9. batch number: EP1566, expiry date: 30.04.2023/XNUMX/XNUMX
10. batch number: EJ7141, expiry date: 30.04.2023/XNUMX/XNUMX
11. batch number: EF2674, expiration date: 30.04.2023/XNUMX/XNUMX
12. batch number: EA7792, expiry date: 30.04.2023/XNUMX/XNUMX
13. batch number: DT1742, expiry date: 30.04.2023/XNUMX/XNUMX
14. batch number: DM5061, expiry date: 30.11.2022/XNUMX/XNUMX
15. batch number: DA9320, expiry date: 30.09.2022/XNUMX/XNUMX 

ACCUPRO 40 (Quinaprilum) 40 mg, film-coated tablets, pack of 28 tablets

1. batch number: FN6679, expiration date: 30.04.2024/XNUMX/XNUMX
2. batch number: FM6646, expiry date: 30.04.2024/XNUMX/XNUMX
3. batch number: FG9088, expiry date: 30.04.2024/XNUMX/XNUMX

Accupro – why was it withdrawn?

«The Main Pharmaceutical Inspectorate received a letter from the representative of the MAH regarding a request for a decision withdrawing from the market the above-mentioned series of medicinal products in connection with confirmation of the presence of an impurity (N-Nitroso-quinapril) above the acceptable daily intake limit.

In connection with the above, the Main Pharmaceutical Inspector decided to withdraw the above-mentioned series of medicinal products in question »- we read in the announcement on the GIF website.

1. Read also: Do you have a drug at home that has just been withdrawn from the market? The doctor tells you what to do

“The occurrence of incompatibility in the medicinal products with which we are dealing in the present case does not require evidence carried out on the possibility of an immediate threat to health or life, because it is enough to justify the potential risk. In this sense, the pharmaceutical inspection has the task of reacting when it is potentially endangered ”- explains the Inspectorate.

Acctupro – in which diseases is it used?

Accupro is a drug from the group of angiotensin converting enzyme inhibitors, which, like all preparations of this group, inhibits the formation of angiotensin II, a substance that causes vasospasm and stimulates the release of aldosterone.

The active substance is quinapril, which belongs to a group of medicines called angiotensin-converting enzyme inhibitors. The common mechanism of action of this group of drugs is based on inhibiting the activity of the enzyme responsible for the formation of angiotensin II (this enzyme is angiotensin converting enzyme, often abbreviated as ACE, which comes from the English name Angiotensin Converting Enzyme).

This preparation is used in the treatment of:

1. essential hypertension (monotherapy or combination therapy)
2. congestive heart failure (treatment in combination with diuretics and / or digitalis glycosides).

Vigantol withdrawn from pharmacies – what batch number?

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).

Responsible entity is P&G Health Germany GmbH.

The packaging of Vigantol with serial number was withdrawn 20CQ046.

Vigantol — why was it withdrawn?

The Main Pharmaceutical Inspectorate on March 11 withdrew from the market the medicinal product VIgantol with the batch number 19KQ193. The basis for the withdrawal was an out-of-specification result for the parameter of active substance content.

«Subsequently, the representative of the MAH P&G Health Germany GmbH informed the authority about the grounds for withdrawing the medicinal product Vigantol from the market with the batch number 20CQ046.

The information provided shows that the action is of a preventive nature and applies to all batches of the Vigantol medicinal product, also those that do not show results beyond the specification »informs GIF.

Vigantol – when is it used?

Vigantol is a drug in the form of oral drops containing vitamin D3. One drop of Vigantol contains 500 units of vitamin D3. The product is intended for children, including infants and premature babies, adolescents and adults.

Vitamin D3 is responsible for the management of calcium and phosphate ions. It increases the absorption of calcium and phosphate in the intestines, increases the reabsorption of calcium in the kidneys and the concentration of these ions in the blood. It inhibits the secretion of parathyroid hormone – a hormone that, among other things, releases calcium from the bones to increase its concentration in the blood. Thus, it facilitates bone mineralization and prevents the loss of calcium from the body.

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.

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