Medicine Quality Alert: Class II Recall of Mesporin 1000mg IM, 2000mg IV, and 500mg IV Injection
Acino AG Munich is initiating a voluntary recall of Mesporin 500mg IV, 1000mg IM, and 2000mg IV, Batch number Z0142Z0153, Z0149, Z0057, Z0107, and Z0086Z0115.
From: Pharmacy and Poisons Board
Published: 15th June 2023
Recall Reference Number: REC/2023/008
Recall Classification: Class II
Recall Level: Retail/Facility level
Marketing Authorization Holder: Acino AG Munich
Local Technical Representative: Laborex Kenya Ltd
Product name: Mesporin 500mg IV, 1000mg IM and 2000mg IV
Active Pharmaceutical Ingredient: Ceftriaxone 1000mg IM, Ceftriaxone 2000mg IV, Ceftriaxone 500 mg IV
Affected Counties: All
Affected batches
Batch Number | Date of Manufacture | Date of expiry |
Z0030Z0129 | 01/02/2022 | 01/02/2025 |
Z0149 | 01/09/2022 | 01/09/2025 |
Z0057 | 01/04/2022 | 01/04/2025 |
Z0107 | 01/06/2022 | 01/06/2025 |
Z0086Z0115 | 01/05/2022 | 01/05/2025
|
Brief description of the problem
This recall is initiated as a precautionary measure following the sporadic discovery of visible particles in the reconstituted powder of the product, in the course of an ongoing investigation by Acino and the related Contract Manufacturing Organisation. According to the investigation’s preliminary outcome, the particles consist of polystyrene.
Action for healthcare professionals
You are advised to immediately stop supplying and quarantine the impacted batches of the product. Goodman Agencies and Laborex Kenya will contact healthcare professionals directly to arrange the return of the products.
Action for patients and carers
No further action is required by patients as this product is usually administered by healthcare professionals in a hospital setting, and the recall is a Retail/Facility level recall.
Further Information
For stock and other enquiries please contact Acino AG Munich. at: qa.germany@acino.swiss. Tel: +49 893221280-10; OR GoodMan Agencies jmunqa@qoodman.co.ke Tel: +254 20 4446664/5/6 OR Laborex Kenya Ltd at: pv.ke@laborex-healthcare.com or saga@laborex-healthcare.com Tel: +254 722335858/+25420693900/137/162
You are advised to promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
For any further information please contact the post-marketing surveillance unit at the Pharmacy and Poisons Board by email at pms@ppb.go.ke
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Medicine Quality Alert: Class II Recall of Mesporin 1000mg IM, 2000mg IV, and 500mg IV