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Medicine Quality Alert: Class I Medicine Recall of Benylin Paediatric Syrup Batch No 329304

The Pharmacy and Poisons Board has mandated Surgipharm Ltd, Kenya, to initiate an urgent recall of Benylin Paediatric Syrup Batch No 329304.

From: Pharmacy and Poisons Board

Published: 11th April 2024

Recall Reference Number: REC/2024/010

Recall Classification: Class I

Recall Level: Consumer-level

Local Technical Representative: Surgipharm Ltd

Manufacturer: Johnson & Johnson (Pty), South Africa

Product name: Benylin Paediatric Syrup

Active Pharmaceutical Ingredient: Diphenhydramine HCL 7mg/5ml

Affected counties: All

Affected Batches

Batch Number

Date of Manufacture

Date of expiry

Pack Size

329304

05/2021

04/2024

100 ml

Brief description of the problem

The Pharmacy and Poisons Board (PPB) is in receipt of information on the medical product alert and recall of Benylin pediatric 100mls cough syrup Batch No 329304 by the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria; due to quality concerns. The quality concerns are unacceptable high level of diethylene glycol that was detected following laboratory analysis by NAFDAC. Diethylene glycol is a contaminant which is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

Action for healthcare professionals

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

Action for patients and caregivers

Patients and members of the public are advised to return the product to the nearest healthcare facility.

Further Information

For inquiries about consignments of the impacted batch, please contact Surgipharm Limited at: info@surgipharm.com, sales@surgipharm.com or marketing@surgipharm.com or Tel: +254 722 204 707, +254 734 224 228

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 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 of Benylin Paediatric Syrup Batch No 329304