Hydrocortisone in the substance for the production of medicines. GIF issued a ban

• One of the pharmacies reported that the packaging of the preparation "contained a powder insoluble in water", while "lidocaine of the same series is in the form of crystals soluble in water"
• The analysis confirmed the quality defect, but the cause of the discrepancy was not clearly established.
• The inspector's decision is immediately enforceable.

The Chief Pharmaceutical Inspectorate has banned the sale and introduction to circulation of a series of anesthetic and antiarrhythmic substances used in a pharmacy formula. This concerns lidocaine hydrochloride monohydrate.

One of the pharmacies reported that the packaging of the preparation "contained a powder insoluble in water", while "lidocaine of the same series is in the form of crystals soluble in water".

The analysis confirmed a quality defect, namely the presence of hydrocortisone in one of the packages of the raw material. As a result, GIF issued a decision to prohibit the sale and withdraw from circulation in Poland a series of substances. They concern:

• Lidocaine hydrochloride monohydrate, 100 mg/100 mg, 1 g package, GTIN 5909991385095,
• batch number 003029, expiry date 09.2027;
• Responsible entity: Production and Trade Company "Galfarm" sp. z o. o. with its registered office in Kraków;
• Marketing Authorisation Number: 13705.

The Inspectorate explains that "the cause of the non-conformity has not been clearly established", therefore it cannot be categorically stated that the confirmed defect does not concern a larger number of packages from the above-mentioned series.

The risk analysis presented in the notification indicated, among other things, that:

• no discrepancies were detected at the plant that might indicate a label mix-up or product mix-up;
• the identity of all archival samples was confirmed;
• the report from the pharmacy is the only complaint of this type on the market;
• it is assumed that the most probable cause of the situation is sticking the label from the lidocaine hydrochloride monohydrate packaging to the hydrocortisone packaging, such action in the factory is excluded.

As we read in the decision, GIF found that "in order to protect the health and life of patients who might take a medicine that does not meet quality requirements, it was necessary to make this decision immediately enforceable."

Lidocaine hydrochloride monohydrate is an active ingredient that acts as a local anesthetic and antiarrhythmic agent. It blocks the conduction of nerve impulses. It also stabilizes the heart's cell membranes, which helps control the heart's rhythm. This treats depolarization-related cardiac arrhythmias , such as ischemia or cardiac glycoside overdose.

The substance is used in: regional anesthesia used in general surgery, urology, orthopedics, gynecology, obstetrics, including for infiltration anesthesia, nerve blocks, nerve trunks, nerve plexuses, and for subarachnoid and epidural diagnostic and therapeutic procedures, as well as in the treatment of ventricular arrhythmias: especially premature contractions and ventricular tachycardia, especially in the context of acute myocardial infarction.

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