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Medicine Quality Alert: Class II Medicine Recall of Nurabucaine (Bupivacaine HCl in Dextrose Injection USP) Batch No. ADA22002

The Pharmacy and Poisons Board has mandated a recall of NURABUCANE (Bupivacaine HCl In Dextrose Injection USP) Batch No. ADA22002

From: Pharmacy and Poisons Board

Published: 07/11/2024

Medicine Recall Reference Number: REC/2024/030

Local Technical Representative: Joshpa Africa Limited

Manufacturer: Farbe Firma, Plot No.: 1508 Gidc, Ankleshwar, Gujarat 393002, India

Product name: Nurabucane

Active Pharmaceutical Ingredient: Bupivacaine HCl in Dextrose Injection USP

Affected counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

ADA22002

11/2022

10/2025

10’s

Brief description of the problem

The product failed to comply with the specifications on assay for dextrose.

Action for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Joshpa Africa Limited, Kenya, who will contact healthcare professionals directly to arrange the return.

Action for patients and carers

No further action is required by patients as healthcare professionals usually administer this product in a hospital setting, and the recall is a Retail/Hospital Pharmacy and Wholesaler/Distributor level recall.

Further Information

For inquiries about consignments of the impacted batch, please contact Joshpa Africa Limited, at: info@jospha.co.ke, joshpador24@gmail.com, or via telephone: +254 711 423341

Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further information please contact the Pharmacy and Poisons Board by email: pms@ppb.go.ke

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Medicine Quality Alert: Class II Medicine Recall of Nurabucaine (Bupivacaine HCl in Dextrose Injection USP) Batch No. ADA22002