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Medicine Quality Alert: Class II Recall of Lidocel (Lidocaine & Adrenaline) Injection Manufactured by Systochem Laboratories Limited

Pro Med Pharmaceuticals Limited has initiated an urgent recall of Lidocel (Lidocaine & Adrenaline) Injection Batch no. 762206 Manufactured by Systochem Laboratories Limited.

From: Pharmacy and Poisons Board

Published: 13th August 2024

Recall Reference Number: REC/2024/015

Recall Classification: Class II

Recall Level: Retail/Facility Level

Local Technical Representative (LTR): Pro Med Pharmaceuticals Limited

Manufacturer: Systochem Laboratories Ltd, India

Product name: Lidocel Injection

Active Pharmaceutical Ingredient: Lidocaine & Adrenaline

Affected counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

762206

11/22

10/25

30ml

 

Brief description of the problem

Pro Med Pharmaceuticals Limited is recalling Lidocel (Lidocaine & Adrenaline) Injection Batch no. 762206 following a market complaint of color change.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing, or use of the above batches immediately. Await contact from Pro Med Pharmaceuticals Limited to arrange the return.

Action for patients and caregivers

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/Hospital Pharmacy and Wholesaler/Distributor level recall.

Further Information

For enquiries about consignments of the impacted batch, please contact Pro Med Pharmaceuticals Limited at: info@promedpharma.co.ke Tel: +254 706 002 005.

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 inquiries and feedback on the product recall, kindly contact the post-marketing surveillance unit of The Pharmacy and Poisons Board Kenya via email at pms@ppb.go.ke

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Medicine Quality Alert: Class II Medicine Recall of Lidocel (Lidocaine & Adrenaline) Injection Manufactured by Systochem Laboratories Limited