Medicine Quality Alert: Class III Medicine Recall of Pharmasal Spray Batch Number 4001, 4002, 4003, 4004 and 4005
Shalina Healthcare (K) Ltd has initiated an urgent voluntary recall of Pharmasal Spray Batch Numbers 4001, 4002, 4003, 4004, and 4005
From: Pharmacy and Poisons Board
Published: 18th November 2024
Recall Reference Number: REC/2024/032
Recall Classification: Class III
Recall Level: Wholesale Level
Local Technical Representative (LTR): Shalina Healthcare (K) Ltd
Manufacturer: Qingyuan Latop Fine Chemicals Limited, China
Product name: Pharmasal spray
Active Pharmaceutical Ingredients: 2-Hydroxyethyl salicylate 5%, Ethyl salicylate 6.4%, Methyl nicotinate 1.6%, Methyl salicylate 7%
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
4001 | 03/2024 | 02/2027 | 150 ml |
4002 | 03/2024 | 02/2027 | 150 ml |
4003 | 03/2024 | 02/2027 | 150 ml |
4004 | 03/2024 | 02/2027 | 150 ml |
4005 | 03/2024 | 02/2027 | 150 ml |
Brief description of the problem
The product is being recalled due to leakage of the product from the cans.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Shalina Healthcare (K) Ltd to arrange the return.
Action for patients and caregivers
No further action is required by patients as this is a Wholesaler/Distributor level recall.
Further Information
For inquiries about consignments of the impacted batch, please contact Shalina Healthcare (K) Ltd at: doreen.moranga@shalina.com or by Telephone at: 254724862585
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 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 III Medicine Recall of Pharmasal Spray Batch Number 4001, 4002, 4003, 4004 and 4005