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:
- 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 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