The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the withdrawal from the market of several batches of Ibuprofen due to a quality defect detected in the tablets.
According to the agency, the affected batches present results outside the specifications in the dissolution tests, which could affect the effectiveness of the medication.
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Although the failure does not pose a serious risk to the health of patients, the AEMPS has decided to proceed with the immediate withdrawal of the affected units to guarantee the quality and safety of the pharmaceutical products available on the market.
The affected medications correspond to two specific presentations: ‘Ibuprofen Pensavital 400 MG film-coated tablets EFG, 20 tablets’ and ‘Ibuprofen Mabo-Farma 400 MG film-coated tablets EFG, 20 tablets’.
These batches do not comply with current regulations and, therefore, cannot continue to be marketed in Spanish pharmacies.
Paracetamol and ibuprofen are two of the most prescribed medications
In the case of ‘Ibuprofen Pensavital 400 mg’, the withdrawal of batch 464X, with an expiration date of July 2026, manufactured by Farmalider SA and marketed by Towa Pharmaceutical SA, has been ordered. Although it does not represent a life-threatening risk to consumers, the AEMPS has urged the return of all distributed units of the affected lot.
Similarly, lots 468X, 469X and 470X of ‘Ibuprofen Mabo-Farma 400 mg’, also manufactured by Farmalider SA and with an expiration date in 2026, have been included in this recall measure.
Ibuprofen is one of the most used analgesics and anti-inflammatories in Spain, especially in the treatment of mild to moderate pain and inflammation.
The 600 mg dose should only be consumed under medical prescription
With this action, the AEMPS reiterates its commitment to pharmacological safety and encourages patients who have purchased any of the affected lots to return them to pharmacies.
Although the detected defect does not represent an imminent danger, the importance of guaranteeing that medicines in circulation meet all established quality standards is emphasized.
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