The batch has been halted for having an “unauthorized version of cases and inserts”
The Spanish Agency for Medicines and Health Products (Aemps), dependent on the Ministry of Health, has issued a health alert and has ordered the withdrawal of a batch of the statin Simvastatin Cinfa 40 mg film-coated tablets EFG. It is a drug used to reduce cholesterol, eliminate triglycerides that circulate in the blood and raise the concentrations of good cholesterol.
Specifically, batch BT1432, with an expiration date of June 30, 2023, from the Cinfa laboratory, has been withdrawn for having an “unauthorized version of cases and prospectuses”. It is a class two defect, intermediate in nature on the scale of three categories of quality defects contemplated by the Aemps. For this reason, it has informed the health authorities so that the product stops being marketed immediately.
The Aemps has ordered the “withdrawal from the market of all distributed units of the affected lots and return to the laboratory through the usual channels.” It also takes the opportunity to remember “the importance of notifying any suspected adverse drug reaction or, in the case of vaccines, of any adverse event”, but that the damage is not greater.
The danger of having cholesterol is due to the accumulation in the walls of the arteries. Over time it can form plaques that narrow the vessels and hinder or prevent blood flow to vital organs. If it continues over time, the ailment can lead to more serious problems such as heart attacks or strokes.
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