The Spanish Medicines Agency has recalled three batches of ibuprofen, two from the Sandoz brand and one from Junifen. As the agency itself indicates in a press release, as part of the annual market control campaign, “three non-compliant results were detected according to the requirements of the European Pharmacopoeia in the total count of mushrooms and yeasts “. The lots withdrawn are:
- Lots G03 and G04 of the drug Ibuprofen Sandoz 40 mg/ml oral suspension (NR 65865, CN 651172)
- Lot H28 of the drug Junifen 40 mg/ml oral suspension (NR 65526, CN 936492).
The batches of Ibuprofen Sandoz 40 mg/ml oral suspension were placed on the market in February 2013 and that of Junifen 40 mg/ml oral suspension in January 2014, so taking into account the usual rotation data, it is predictable that they will only stay in the pharmacy. channel a small number of units.
THE contamination of these medications by yeast in a title higher than that required by the European Pharmacopoeia, in principle, should have no clinical impact on patientssince it is a microorganism which, on the one hand, is the usual flora of the environment and of man, and on the other hand, is administered orally, therefore after ingestion it would be destroyed by pH and/or intestinal enzymes.
However, in immunocompromised patients or in other special situations, the ingestion of a high inoculum of these microorganisms could pose a risk to their health.
This is why the Director of AEMPS ordered on July 25, 2014 the preventive immobilization of these batches of the two drugs, while the contradictory analyzes requested by the laboratories holding the authorization for these drugs are carried out.
