The Spanish medicines agency (Aemps) has ordered the withdrawal from the market of all the distributed units of the Tuselin Decongestant, lot N-01, due to a defect in the product and has ordered their return to the laboratory.
The Tuselin Decongestant (2 mg/ml and 1 mg/ml syrup in 200ml bottles) is a used in the treatment of irritating and nervous coughs and nasal congestion in adults, adolescents and children from the age of six and is marketed by Korhispana SL.
The batch affected by the recall is N-01, with an expiry date 03/31/2024. The registration number is 47622 and the national code is 757146.
In a statement, Aemps said that the defect detected in this drug is the "out-of-specification result in the content of phenylephrine hydrochloride, dextromethorphan hydrobromide and sorbic acid (preservative) in the 20-month stability studies."