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:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS, both on Android and iOS
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
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Medicine Quality Alert: Class I Medicine Recall Lumidol Injection (Paracetamol 1% W/V injection) Batch Numbers CM4594007, CM4594008, and CM4594009