The Chief Pharmaceutical Inspector has issued a decision to withdraw four series of the popular drug Magne B6 in the form of film-coated tablets from the market. The reason is that these series did not meet the quality requirements for one of the key ingredients - vitamin B6.
4 series of Magne B6 withdrawn from the market
Published June 27, 2025 09:37
Źródło: GIF
On June 24, 2025, the Chief Pharmaceutical Inspector issued Decision No. 20/WC/ZW/2025, to withdraw from marketing throughout Poland four batches of the medicinal product Magne B6 (Magnesii lactas dihydricus + Pyridoxini hydrochloridum) in the form of film-coated tablets (48 mg Mg²⁺ + 5 mg), package of 60 tablets, GTIN 05902502992744.
The decision covered the following series:
- GV380 (expiration date: 06.2025),
- GV381 (expiration date: 06.2025),
- GV382 (expiration date: 06.2025),
- HV006 (expiration date: 12.2025).
The entity responsible for the product is Opella Healthcare Poland sp. z o.o., based in Warsaw. GIF not only ordered the withdrawal of the indicated series, but also banned its further marketing. The decision was given the order of immediate enforceability.
The reason for the decision was the results of long-term stability studies, which showed insufficient release of pyridoxine hydrochloride (vitamin B6) - a substance essential to the drug's effectiveness. These results were inconsistent with the requirements of the quality specification applicable to the Polish market.
Although the manufacturer attempted to halt the proceedings by presenting, among other things, the results of archival tests on samples stored under different conditions, the GIF considered this evidence insufficient. The authority stressed that only tests under recorded storage conditions (so-called stability tests) are authoritative in assessing product quality.
Source: GIF
Topics
GIF / Główny Inspektor Farmaceutyczny / wycofanie leku / Magne B6 / badania stabilności / jakość leku / witamina B6
