The Spanish Agency of Medicines and Health Products (Aemps) has ordered the withdrawal “preventative” of the market of all units of seven lots of the medication Efferalgan Pediatric oral solution, in bottle of 90 ml., upon discovery of particles of polyurethane in the packaging machine.
The withdrawal was made at the request of the laboratory owner, according to the Aemps.
even Though “it is not possible to ensure that some units of the medicine have not been contaminated”, indicates the agency, has not been observed pollution in the units reviewed, nor has it received any claim or notification of “adverse event” associated with this problem.
In an alert pharmaceutical, the Aemps has ordered the return to the laboratory all of the units in the batch N9475, P2007, P4102, P5130, P8287, R1671, and R4129 of this drug, whose active ingredient is acetaminophen, and is indicated to treat fever and relieve mild to moderate pain in children.
The alerts pharmaceutical are classified in three classes, being class II, assigned to this withdrawal, corresponding to defects of quality which do not pose a serious health risk.
In this particular case, it is a measure of “caution”, given that the risk is only “potential”, not having detected the presence of particles in the solutions available on the market, insists the Aemps.
Efferalgan Pediatric oral solution in bottle of 90 ml. is manufactured by the laboratory of French UPSA and marketed in Spain by Bristol-Myers Squibb.
The autonomous communities will be in charge of doing the follow-up of withdrawal medication