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Medicine Quality Alert: Class II Product Recall of Biodine Mouth Gargle by Biodeal Laboratories Limited

Biodeal Laboratories Limited is recalling six batches of Biodine Mouth Gargle due to discoloration of the product; the batches 0122081, 0122082, 0322054, 0322055, 0322056 & 0322057.

From: Pharmacy and Poisons Board

Published: 12th September 2022

Recall Reference Number: REC/2022/08

Recall Classification: Class II

Recall Level: Retail/Facility Level

Manufacturer: Biodeal Laboratories Limited, Kenya

Product name: Biodine Mouth Gargle

Active Pharmaceutical Ingredient: Povidone iodine 1% w/v

Affected Batches

Batch number

Expiry date

Pack Size

0122081

12/2023

100ml

0122082

12/2023

100ml

0322054

12/2023

100ml

0322055

12/2023

100ml

0322056

12/2023

100ml

0322057

12/2023

100ml

Brief description of the problem

The above six batches of Biodine Mouth Gargle had changed color to colorless.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing or use of batch batches 0122081, 0122082, 0322054, 0322055, 0322056 & 0322057  immediately and await contact from Biodeal Laboratories Limited team to arrange for the return of the products.

Action for patients

Biodine Mouth Gargle is used as an antiseptic. Talk to your prescribing healthcare professional if you have the above batches of Biodine Mouth Gargle.

Further Information

For any enquiries on consignments of the products, please contact Biodeal Laboratories Limited by email at regulatoryaffairs@biodealkenya.com or by phone at +254 720 333 829.

Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further information please contact the Pharmacy and Poisons Board by email: pms@ppb.go.ke

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Medicine Quality Alert: Class II Product Recall of Biodine Mouth Gargle by Biodeal Laboratories Limited