PPB - Services

Complaints, Feedback and Enquiry

Medicine Quality Alert: Class I Medicine Recall Lumidol Injection (Paracetamol 1% W/V injection) Batch Numbers CM4594007, CM4594008, and CM4594009

The Pharmacy and Poisons Board has mandated Zawadi Healthcare Ltd to recall Lumidol Injection (Paracetamol 1% W/V injection) Batch Numbers CM4594007, CM4594008, and CM4594009

From: Pharmacy and Poisons Board

Date of Recall Initiation: 24th April 2025

Recall Reference Number: REC/2025/016

Recall Classification: Class I

Recall Level: Retail/Facility level

Manufacturer: KamlaAmrut Pharmaceutical LLP, India.

Local Technical Representative (LTR): Zawadi Healthcare Ltd

Product name: Lumidol

Active Pharmaceutical Ingredient: Paracetamol 1% W/V injection

Affected counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

CM4594007

11/2024

10/2026

100ml

CM4594008

11/2024

10/2026

100ml

CM4594009

11/2024

10/2026

100ml

Brief description of the problem

The product is being recalled due to market complaints about the color change of the product to black.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing, or use of the above batches immediately. Await contact from Zawadi Healthcare Ltd to arrange the return.

Action for patients and caregivers

No further action is required by patients as this is a Retail/hospital Pharmacy and Wholesaler/Distributor level recall.

Further Information

For inquiries about consignments of the impacted batch, please contact Zawadi Healthcare Ltd at: regulatory@zawadihealthcare.com or bhatt@zawadihealthcare.com, or by Telephone at: +254 784 882 278 / +254 784 882 279

You are advised to 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, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke

Download document

Medicine Quality Alert: Class I Medicine Recall Lumidol Injection (Paracetamol 1% W/V injection) Batch Numbers CM4594007, CM4594008, and CM4594009