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Health withdraws a batch of a medication to treat hypertension

The Spanish Agency for Medicines and Health Products (AEMPS) has warned of the withdrawal of a batch of Enalapril, a medication to treat hypertension, symptomatic heart failure and for the prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction.

Specifically, the affected batch is 499R of Enalapril Alter 20 mg EFG tablets, with an expiration date of July 31, 2023.

As explained by the AEMPS on its website, the description of the defect is as follows: “Result outside of specifications in the assessment, hardness and related substances tests.” As a solution, the agency has dictated the “withdrawal from the market of all distributed units of the affected batches and return to the laboratory through the usual channels.”

Last June, the AEMPS issued another warning about another affected batch and about which it reported: “result out of specifications in stability studies, in the assessment test” of batch P575 of Enalapril/Hydrochlorothiazide Stada 20/12, 5 mg EFG tablets with an expiration date of August 31, 2023.