EOF recalls batches of three pharmaceutical products

EOF is recalling batches of three medicines, according to announcements released today, Thursday (12/03).

Specifically, the medicines concerned are:

• SULBENIN F.C. TAB 5MG/TAB BTx28 tabs
• Rivaroxaban Tablets 20 mg
• FLAGYL 500 mg/cap

Recall of batch 25A150 of SULBENIN F.C. TAB 5MG/TAB BTx28 tabs

EOF has ordered the recall of batch 25A150 of the medicinal product SULBENIN F.C. TAB 5MG/TAB (BTx28 tabs) due to an incorrect expiry date entry on the EOF electronic platform.

It is emphasized that this batch does not present any quality issue.

The company ANFARM HELLAS S.A. must immediately contact the recipients of the product and withdraw the specific batch from the market.

Recall documentation must be kept for at least five (5) years and made available to EOF if requested.

Recall of a batch of Rivaroxaban Tablets 20 mg

EOF has also ordered the recall of final product batch 8211799, with expiry date 06/2028, of Rivaroxaban Tablets 20 mg, after an out-of-specification result was identified during impurity testing.

This decision has been issued as a precautionary measure, pending the completion of the evaluation by the European Medicines Agency (EMA).

The company Viatris Hellas must immediately contact the batch recipients and withdraw it from the market within a reasonable timeframe. Relevant documentation must be retained for at least five (5) years and provided to EOF if requested.

Recall of batch 41015 of FLAGYL 500 mg/cap

EOF has also ordered the recall of batch 41015 of the medicinal product FLAGYL 500 mg/cap, with expiry date 10/2028, after a foreign body was detected in one package.

The company LAVIPHARM S.A. must immediately contact recipients and withdraw the specific batch from the market.

Recall documentation must be kept for at least five (5) years and made available to EOF if requested.