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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:

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