Medicine Quality Alert: Class II Medicine Recall of Painil (Paracetamol Suspension) Batch Number 59014, 59114, 59314 and 59414
Njimia (K) Limited has initiated the urgent recall of Painil Suspension, Batch No. 59014,59114,59314 and 59414 due to color change
From: Pharmacy and Poisons Board
Published: 17/07/2024
Recall Reference Number: REC/2024/014
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Njimia (K) Limited
Product name: Painil
Active Pharmaceutical Ingredient: Paracetamol Suspension 120mg/5ml
Affected Counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
59014 | 03/24 | 02/27 | 60ml |
59114 | 04/24 | 03/27 | 60ml |
59314 | 04/24 | 03/27 | 60ml |
59414 | 04/24 | 03/27 | 60ml |
Brief description of the problem
The product is being recalled following a color change from pink to brown. The product failed to comply with the specifications on the description as per market authorization requirements.
Action for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Njimia (K) Limited, Kenya, who will contact healthcare professionals directly to arrange the return.
Action for patients and carers
Patients currently prescribed Painil (Paracetamol Suspension) Batch No.59014,59114,59314,59414 should be contacted by their prescribing healthcare professional. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options.
Further Information
For medical information enquiries please contact Njimia (K) Limited, at: dwachira@njimia.co.ke, qa@njimiakenya.co.ke or via telephone: + 254 (0) 709770100
Promptly report any cases 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 Android and iOS
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 Painil (Paracetamol Suspension) Batch Number 59014, 59114, 59314, 59414