Medicines Quality Alert: Class II recall of Rocephin 1g IV by Roche Kenya Limited
Roche Kenya is conducting a voluntary recall of Rocephin 1g IV, batch B0752B04 due to the detection of pinholes in 10 mL Water for Injections (WFI).
From: Pharmacy and Poisons Board
Published: 01/07/2022
Recall Reference Number: REC/2022/07
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: F. Hoffmann-La Roche Ltd, Kaiseraugst
Local Technical Representative: Roche Kenya
Product name: Rocephin 1g IV
Active Pharmaceutical Ingredient: Ceftriaxone
Affected Batch
Batch number | Expiry date | Pack size |
B0752B04 | 03/2024 | 1 vial with 1g active ingredient + 1 ampoule with 10 ml solvent |
Brief description of the problem
One batch of Rocephin 1g IV had pinholes in 10mL Water for Injection (WFI).
Advice for healthcare professionals
You are advised to immediately quarantine and to stop supplying the impacted batch of the product. Roche Kenya will contact you to arrange for the return of the product.
Advice for patients
No action is required for patients as this product is administered in the healthcare facility setting.
Further Information
For stock enquiries please contact Roche Kenya Limited by email at: joyce.mbithi@roche.com or via telephone: +254 733 455 532
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 Pharmacy and Poisons Board by email: pms@ppb.go.ke
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Medicines Quality Alert: Class II recall of Rocephin 1g IV by Roche Kenya Limited