GIF recalls painkiller gel and anticancer drug. Find out the details of the decision

The GIF messages refer to Vblaast 10 Vinblastine Sulfate and Reparil Gel N. The first product is used in the treatment of cancer diseases, including testicular cancer, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. The second of the indicated preparations is used to alleviate the symptoms accompanying injuries, such as contusions, hematomas, crushing and joint injuries. The gel has anti-inflammatory, analgesic and anti-swelling properties.

Vblast 10 – GIF decision details

The Chief Pharmaceutical Inspectorate has decided to withdraw the following batch of the preparation from the market Vblast 10 Vinblastine Sulfate:

• drug form: vial,

• drug quantity: 10 mg/10 ml,

• series number: I23I011B,

• expiry date: August 31, 2025,

• responsible entity: VAMA LIFECARE PVT. LTD. based in India,

• entity that has obtained consent for the temporary marketing authorization of the above-mentioned medicinal product: Genesis Pharm sp. z o. o. sp. komandytowa, ul. Obywatelska 128/152, 94-104 Łódź.

GIF also decided to prohibit the introduction of the indicated batch of the drug for sale in the territory of the Republic of Poland. Both decisions were made immediately enforceable. Their reason was the detection of a quality defect in the mentioned series of the product. Crystals of unidentified origin, visible to the naked eye, were found there. “It should be emphasized that the occurrence of such a quality irregularity creates a real danger resulting from the risk of such crystals entering the patient’s bloodstream, which may lead to unpredictable negative health effects. For the above reasons, despite the impossibility of comparing the findings made by the authority with the source documentation of the medicinal product, the Chief Pharmaceutical Inspector found that the identified irregularities constitute a departure from the quality requirements established for the medicinal product of significant importance (quality defect) and considered it justified and necessary to eliminate the said series of a medicinal product from domestic circulation,” we read in the announcement made available by GIF.

Reparil Gel N – GIF resolution

The Chief Pharmaceutical Inspectorate has suspended the sale of the drug in the country – Reparil Gel N (Escinum + Diethylamini salicylas), gel, (10 mg + 50 mg)/g, packaging 1 tube 40 g, GTIN 05909990116614. The responsible entity is Mylan Healthcare sp. z o. o. based in Warsaw. The GIF decision applies to the following product series:

• batch number: D1900226, expiry date: 02/2024,

• batch number: D2001785, expiration date: 02/2025,

• batch number: D2001039, expiry date: 02/2025,

• batch number: D2000440, expiry date: 01/2025,

• batch number: D2000974, expiry date: 12/2024,

• batch number: D1903726, expiry date: 08/2024,

• batch number: D2102011, expiration date: 03/2026,

• batch number: D2102021, expiry date: 03/2026,

• batch number: D2200054, expiry date: 01/2027,

• batch number: D2101749, expiry date: 08/2026,

• batch number: D2103655, expiry date: 08/2026,

• batch number: D2100538, expiry date: 03/2026,

• batch number: D2201197, expiry date: 01/2027,

• batch number: D2200248, expiry date: 02/2027,

• batch number: D2201438, expiry date: 02/2027,

• batch number: D2201198, expiry date: 01/2027,

• batch number: D2201426, expiry date: 02/2027,

• batch number: D1903725, expiry date: 08/2024,

• batch number: D1901568, expiration date: 02/2024,

• batch number: D2001038, expiry date: 03/2025,

• batch number: D1901567, expiration date: 02/2024,

• batch number: D1902417, expiry date: 08/2024,

• batch number: D2001843, expiry date: 02/2025,

• batch number: D2002129, expiry date: 03/2025,

• batch number: D2002134, expiry date: 03/2025,

• batch number: D2002135, expiration date: 03/2025,

• batch number: D1903721, expiry date: 08/2024,

• batch number: D1901585, expiry date: 02/2024,

• batch number: D2001872, expiry date: 02/2025,

• batch number: D2000931, expiry date: 12/2024,

• batch number: D2001440, expiry date: 01/2025,

• batch number: D2201557, expiry date: 06/2027,

• batch number: D2301227-1, expiration date: 11/2027,

• batch number: D2300029, expiration date: 10/2027,

• batch number: D2202531, expiration date: 10/2027,

• batch number: D2202992, expiry date: 06/2027.

A quality defect was detected in the indicated batches of the drug. It’s about too much aescinol. “The acceptance criteria for quality specification parameters indicated in the registration documentation of a medicinal product are established based on extensive research on the safety of use of this product. Therefore, any exceeding of these limits must be considered a circumstance constituting a real and direct threat to the health or life of patients – until the reason for the deviation is clearly identified and it is proven that it does not constitute such a threat,” GIF said in the justification of the decision.