Information on the recall of Thymoglobuline 25 mg powder for solution for infusion
The company sanofi-aventis Croatia d.o.o., the marketing authorisation holder for Thymoglobuline 25 mg powder for solution for infusion has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the decision to recall the batches of the above mentioned medicinal product, because the product’s manufacturer found that it fell out of specification during ongoing stability study. This batch has shown adverse trends in the molecular size distribution test, with results approaching the upper limit of 5.0% for polymers, aggregates and fragments.
This event is due to a technical problem associated with preventive system maintenance during the preparation of the lyophilisate containing vial with closure, occurred in March 2011. Ever since, all affected batches manufactured in that period , from March to November 2011, are included in the monthly monitoring program. Corrective measure were implemented at the manufacturing site in November 2011 and the problem was sold.
The decision about the recall of ten batches (C1272, C1274, C1280, C1282, C1284, C1286, C1300, C1304, C1306 and C1310) of the medicinal product was taken based on the results showing an out of specification risk before the expiry date for these batches. An out of specification result was found for the batch C1274, expiry date 03/2014, that was not on the Croatian market.
The recall has been initiated for the following batches on the Croatian market: C1272H05, C1272H19, C1282H11, C1282H42, C1306H03 and C1306H23. The recall is preventive and is performed to the wholesalers’ level. The marketing authorisation holder will inform them about the recall. The recall of the above mentioned batches does not affect the regular supply chain with Thymoglobuline 25 mg powder for solution for injection as other batches not affected by this problem are available on the market.
Other batches manufactured in the affected period, from March to November 2011 and included in the three months monitoring programme, are currently within the specification limit and it is estimated that the parameters will be satisfying by the end of expiry date. The company Sanofi will continue with the three months monitoring period by the end of expiry date.
No safety risks have been identified, neither for out of specification batches, nor for other batches within the specifications. It is estimated that theoretically there is an increased risk of anaphylaxis and serum disease associated with out of specification results for Thymoglobuline. However, this theoretic risk is considered low.
Since this problem was identified in 2011, HALMED has not received any adverse reaction report in connexion with this medicinal product.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.