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Quality Alert: Class II Recall of Sodium Hypochlorite (TBcide™)

Kenya Medical Research Institute has initiated an urgent voluntary recall of Sodium Hypochlorite (TBcide™) batch numbers 24052101A2 and 24052201A2

From: Pharmacy and Poisons Board

Date of Recall Initiation: 16th January, 2025

Recall Reference Number: REC/2025/003

Recall Classification: Class II

Recall Level: Retail/Facility level

Manufacturer: Kenya Medical Research Institute

Product name: TBcide™

Active Pharmaceutical Ingredient: Sodium Hypochlorite

Affected counties: All

Affected Batches

Batch Number

Date of Manufacture

Date of expiry

Pack Size

24052101A2

05/2024

10/2025

5 litres Jerrycan

24052201A2

05/2024

10/2025

5 litres Jerrycan

Brief description of the problem

The recall has been initiated due to market complaints on lack of the characteristic color and smell as well as formation of brown crystals on the product packaging.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Kenya Medical Research Institute 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.

Further Information

For inquiries about consignments of the impacted batches, please contact Kenya Medical Research Institute at: director@kemri.go.ke or by Telephone at: 0722 205 901

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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Quality Alert: Class II Recall of Sodium Hypochlorite (TBcide™)