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Wednesday, June 12, 2024

Trazodone Neuraxpharm. Suspension of marketing of a drug due to a quality defect

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Four batches of the Trazodone Neuraxpharm medicinal product have been suspended from circulation – informed the Chief Pharmaceutical Inspector (GIF). The reason for the decision is the failure to meet quality standards. Trazodone is a prescription drug used to treat symptoms of depression.

The Chief Pharmaceutical Inspector announced the suspension of trade in the medicinal product throughout the country: Trazodone NeuraxpharmTrazodoni hydrochloridum, 100 mg, tablets, pack of 30 tablets, GTIN 05909991373290, entity responsible: Neuraxpharm Arzneimittel GmbH based in Langenfeld, Germany in the following series:

– batch number: P2200932 expiration date: 01/2024, – batch number: P2200933 expiration date: 01/2024, – batch number: P2205459 expiration date: 01/2024, – batch number: P2206612 expiration date: 10/2024.

The GIF’s decision is “immediately enforceable”.

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Result outside quality specifications

As we read in the justification of the decision, Neuraxpharm Polska sp. z o. o., the representative of the entity responsible for the Trazodone medicinal product Neuraxpharm, provided information about “the result obtained outside the quality specification (OOS) in the stability test for the hardness parameter.”

“As a result of the analysis of stability data, taking into account the type of immediate packaging, it was also established that the product packed using different types of foil, accepted in the registration process, has different values ​​for the hardness parameter. This may prove a different impact of gas permeability through the immediate packaging (blisters). , made of various types of foil, for the medicinal product in question,” GIF indicates in the announcement.

Main photo source: Shutterstock



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