The Spanish Agency for Medicines and Health Products (AEMPS) has taken a batch of Junifen medicine as a precaution in syrup because it has fungus and yeast count outside the required levels.
Junifen is an ibuprofen for pediatric use that occurs in 150 ml bottles, and all units of the lot G07 in syrup (Junifen 4% oral suspension) due to an "out-of-specification result (total fungus and fork count)".
The precautionary measures adopted are notified on the AEMPS website: withdrawal of all distributed units from lot G07 from the market and return to the laboratory by the usual channels.
If you have at home the medicine corresponding to affected lot of Junifen, you have to take it to the pharmacy. It is assumed that the rest of the lots available in the market do not present anomalies and can continue to be taken normally.
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Regarding the withdrawal of lot G07 of the drug JUNIFEN 4% oral suspension, 1 bottle of 150 ml and due to the numerous inquiries received, AEMPS has issued a new note expanding the information with the following clarifications: This withdrawal is framed within the results of the annual market control campaign in which, with the collaboration of the health authorities of the autonomous communities, samples of different medicines are collected and subsequently analyzed in the official laboratories of control of the AEMPS In the case of this medicine, two batches were collected resulting in one of them as not conforming to the specification "total yeast and fungus count" and in particular to the count of a yeast. The contamination of the medicine by a yeast in a count higher than that required by the Pharmacopoeia, in principle, has no clinical repercussion for the patient, since it is a microorganism, which on the one hand, is a habitual flora of the environment and on the other hand , is administered orally, so after ingestion it would be destroyed by pH and / or intestinal enzymes. The finding of this type of microorganisms, given the count obtained, should, however, be interpreted as suggestive of improper manufacturing. If we are using or have used this medicine, the batch number must be checked: In any case, from AEMPS they warn that having consumed the drug JUNIFEN 4% oral suspension, 1 bottle of 150 ml, of lot G07 does not represent a health risk.
