Medicine Quality Alert: Class II Medicine Recall of Atravita Injection 10mg/ml (Atracurium Besylate BP 10mg) Batch No. V21153
The Pharmacy and Poisons Board has mandated Reddys Pharma Limited to initiate an urgent recall of Atravita Injection 10mg/ml (Atracurium Besylate BP 10mg) Batch No. V21153, Manufactured by Vital Healthcare Pvt Limited.
From: Pharmacy and Poisons Board
Published: 18th July 2024
Recall Reference Number: REC/2024/016
Recall Classification: Class II
Recall Level: Retail/Facility Level
Local Technical Representative (LTR): Reddys Pharma Limited
Manufacturer: Vital Healthcare Pvt Limited
Product name: Atravita Injection
Active Pharmaceutical Ingredient: Atracurium Besylate BP 10mg
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
V21153 | 08/21 | 07/24 | 10´2.5ml Ampoule |
Brief description of the problem
The Pharmacy and Poisons Board has mandated Reddys Pharma Limited to initiate an urgent recall of Atravita Injection 10mg/ml (Atracurium Besylate BP 10mg) Batch No. V21153, Manufactured by Vital Healthcare Pvt Limited due to failure to comply with the test parameter on assay.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Reddys Pharma Limited to arrange the return.
Action for patients and caregivers
No further action is required by patients as this product is administered in a healthcare facility setting and this is a Retail/hospital Pharmacy and Wholesaler/Distributor level recall.
Further Information
For enquiries about consignments of the impacted batch, please contact Reddys Pharma Limited at: admin@reddyspharma.com, info@reddyspharma.com Tel: +254-788-797777
Promptly report any case(s) 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#
- Mobile application: mPvERS both Android & iOS
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
For any further enquiries and feedback on the product recall, kindly contact the post-marketing surveillance unit of The Pharmacy and Poisons Board Kenya “the Board” via email at pms@ppb.go.ke
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Medicine Quality Alert: Class II Medicine Recall of Atravita Injection 10mg/ml (Atracurium Besylate BP 10mg) Batch No. V21153