Medicine Quality Alert: Class II Recall of Umbicare Gel manufactured by Indoco Remedies Ltd
Sai Pharmaceuticals(Kenya)Ltd is implementing a voluntary recall of Umbicare Gel Batch number UA1M11C1B due to out-of-specification analysis results on related substances test.
From: Pharmacy and Poisons Board
Published: 13/12/2022
Recall Reference Number: REC/2022/10
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Indoco Remedies Limited, India
Local Technical Representative: Sai Pharmaceuticals(Kenya)Ltd
Product name: Umbicare Gel
Active Pharmaceutical Ingredient: Chlorhexidine Gluconate 7.1%w/w
Affected Batch
Batch number | Expiry date | Pack size |
UA1M1IC1B | 08/2023 | 5g |
Brief description of the problem
One batch of Umbicare Gel; UA1M11C1B had out-of-specification analysis results on related substances test.
Action for healthcare professionals
You are advised to immediately quarantine and stop supplying the remaining stocks of the impacted batches of the product. Sai pharmaceuticals will contact you to arrange for the return of the product.
Action for patients and carers
This recall is at the retail and wholesaler level and not directed to the patient level. Umbicare Gel is used as an antiseptic for the management of umbilical cord wounds in infants. Carers for patients who have been prescribed the impacted batches are advised to seek medical advice from their healthcare providers.
Further Information
For stock enquiries, please contact Sai Pharmaceuticals (Kenya) Ltd by email at head-regulatory@saipharm.com or by phone at +254 731 952 330.
You are advised to 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 Recall of Umbicare Gel manufactured by Indoco Remedies Ltd