The EOF announced the recall of batches of the medicinal product KEPPRA Oral Sol 100mg/ml 150ml bottle + 1 Syringe 3ml.
KEPPRA Oral Sol 100mg/ml 150ml bottle + 1 Syringe 3ml is a solution for inhalation under pressure. The recall, as stated in the EOF announcement, concerns the lots:
a) 23I08 (expiration date: 31/08/2026)
b) 23I13 (expiration date: 31/08/2026) and
c) 23J10 (end date: 30/09/2026)
The defect concerns the syringe that accompanies the product, in which the red ink of the dosage marking was observed to detach.
As the EOF notes in its announcement, “the decision on the recall is issued in the context of the defense of public health in order to strengthen the voluntary recall of the company UCB PHARMA SA BELGIUM.
The company UCB AE must immediately contact the recipients of the specific batches, namely pharmacies and drug warehouses, and withdraw them from the market within a reasonable period of time.
The relevant documents are kept for a period of at least five years and are brought to the attention of the EOF, if requested”.
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