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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:

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