Specifically, the recall of the two batches: a) 1209271 (expiry date: 07/2025) and b) 1303568 (expiry date: 03/2026), of the pharmaceutical product ARPOYA TABS 30mg BT X 28 TABS, (REF CODE 308300402 ).
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30/10/2024
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11:12
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Following an inspection by the MAH, the two mentioned batches were found to be out of specification in terms of the content of the active substance, which was found to be elevated to 107.8% in the first batch and 108.9% in the second batch.
The decision was issued in the context of defending public health. The company Innovis Pharma SA must immediately contact the recipients of the specific batches, namely pharmacies and pharmaceutical 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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