Medicine Quality Alert: Class II Medicine Recall of Cloxam Dry Syrup (Ampicillin/Cloxacillin) Batch No. 00066CXS
Sphinx Pharmaceuticals Ltd has initiated an urgent voluntary recall of Cloxam Dry Syrup (Cloxacillin/Ampicillin), Batch No. 00066CXS
From: Pharmacy and Poisons Board
Date of Recall Initiation: 30th September 2025
Recall Reference Number: REC/2025/031
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Sphinx Pharmaceuticals Ltd, Kenya
Product name: Cloxam Dry Syrup
Active Pharmaceutical Ingredient: Ampicillin/Cloxacillin 125mg and 125mg/5ml
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
00066CXS | 01/2023 | 12/2025 | 100ml |
Brief description of the problem
The product did not meet the specification for appearance, which requires it to be an off white powder. Instead, brown particles were observed dispersed throughout the powder and at the base of the bottle.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batch immediately. Await contact from Sphinx Pharmaceuticals 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. You are advised to talk to your healthcare professional if you have the above batch of Cloxam Dry Syrup. The patients should continue taking other batches of the product, other than the impacted batch, and as prescribed by the healthcare professional.
Further Information
For inquiries about consignments of the impacted batch, please contact Sphinx Pharmaceuticals Ltd at: qaoffice@sphinx.co.ke, sphinx @sphinx.co.ke, or by Telephone at: +254 722 565 305
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 II Medicine Recall of Cloxam Dry Syrup (Cloxacillin/Ampicillin) Batch No. 00066CXS