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Quality Alert: Class II Recall of Formalin (Formaldehyde Solution) Batch No. 5D12031 Manufactured by Impact Chemicals Ltd

The Pharmacy and Poisons Board has mandated the recall of Formalin (Formaldehyde Solution) Batch No. 5D12031 Manufactured by Impact Chemicals Ltd.

From: Pharmacy and Poisons Board

Published: 11th May 2026

Recall Reference Number: REC/2026/12

Recall Classification: Class II

Recall Level: Retail/Facility Level

Manufacturer: Impact Chemicals Ltd

Product name: Formalin

Active Pharmaceutical Ingredient: Formaldehyde Solution

Affected counties: All

Affected Batches

S/N

Batch No

Mfg Date

Exp Date

Pack Size

1.      

5D12031

04/2025

04/2028

Jerrican

Brief description of the problem

Following Post Market Surveillance activities, the Board conducted sampling of Formalin (Formaldehyde Solution) Batch No. 5D12031 Manufactured by Impact Chemicals Ltd. Upon analysis, the product batch failed to comply with the specification of the appearance parameter whereby the solution exhibited white precipitate at the bottom of the container.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing, or use of Formalin (Formaldehyde Solution) Batch No. 5D12031 immediately, and contact Impact Chemicals Ltd to arrange return.

Further Information

For any inquiries on consignments please contact Impact Chemicals Ltd, by email at sales@impactchemicals.co.ke or via telephone at 0702934906

Promptly report any case/s of suspected substandard and falsified products or adverse reactions or insufficient control of symptoms to the nearest healthcare facility or the Pharmacy and Poisons Board 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 Formalin (Formaldehyde Solution) Batch No. 5D12031 Manufactured by Impact Chemicals Ltd