The Chief Pharmaceutical Inspector (GIF) issued a decision to withdraw from the market the pharmaceutical raw material used, among others, for the production of prescription medicines for children. The reason is a serious quality error.
We are talking about Sildenafil citrate – it is a pharmaceutical raw material, i.e. a drug ingredient that can be used to prepare prescription drugs in pharmacies. Although it may be associated primarily with potency medications (sildenafil), it is also used to create medications for children suffering from pulmonary hypertension.
Why is pharmaceutical raw material being phased out?
According to GIF, in the collective packaging of another pharmaceutical raw material there was a vial with the label of Sildenafil citrate. Specialists see two possible reasons for this state of affairs: either the labels were mixed up, or a vial of another preparation was mistakenly packed in the wrong place. The problem is that it is not possible to organoleptically notice the difference between the preparations, hence the GIF decided that it was a serious quality defect and made its decisions – to withdraw from the market and ban the introduction of specific series – immediately enforceable.
GIF explains its decision by the possible risk to patients’ health, regardless of the situation. “If it is assumed that the description of the unit packaging of a pharmaceutical raw material is inconsistent with its actual content, the risk of using an incorrect substance in the process of preparing a prescription drug increases. However, if the package contains a pharmaceutical raw material whose name corresponds to the description on the package (i.e. sildenafil citrate), incorrect marking of the batch number may prevent the pharmacy staff from responding properly to any reports of possible quality defects occurring in specific batches of this raw material. However, an incorrectly determined expiry date may lead to the use of the raw material after the date in which there is no guarantee of its effectiveness and safety,” we read in the justification.
Pharmaceutical raw material being withdrawn – details
In its announcements, GIF provided details about the batch of raw material in which the defect occurred. This:
- Sildenafil citrate (Sildenafili citras)1 g package, GTIN 5909991221980 for packages marked with the following batch numbers: batch number:
229953, expiration date: July 31, 2025;
batch number: 229655, expiration date: July 31, 2025;
batch number: 231874, expiration date: December 31, 2026
- Sildenafil citrate (Sildenafili citras)5 g package, GTIN 5909991221997 for packages marked with the following batch numbers:
batch number: 229656, expiry date: July 31, 2025
- entity responsible: Fagron sp. zoo based in Krakow.