Medicine Quality Alert: Class II Medicine Recall of Steramine (Betamethasone and Dexchlorpheniramine) Tablets Batch No. BPL783A and BPL409A
The Pharmacy and Poisons Board has mandated Biopharma Ltd to initiate an urgent recall of Steramine (betamethasone and dexchlorpheniramine) tablets batch no. BPL783A and BPL409A
From: Pharmacy and Poisons Board
Date of Recall Initiation: 20/08/2025
Recall Reference Number: REC/2025/029
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Biopharma Ltd
Product name: Steramine Tablets
Active Pharmaceutical Ingredient: betamethasone USP 0.25 mg and dexchlorpheniramine USP 2 mg
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
BPL783A | 04/2024 | 03/2027 | 30s |
BPL409A | 10/2023 | 09/2026 | 30s |
Brief description of the problem
The product batches are being recalled due to failure to comply with identification by HPLC test for betamethasone and assay for both betamethasone and dexchlorpheniramine Maleate. The product batches were sampled during risk-based post-marketing surveillance activities.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Biopharma Ltd 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. You are advised to talk to your healthcare professional if you have the above batches of Steramine tablets.
Further Information
For inquiries about consignments of the impacted batches, please contact Biopharma Ltd at: info@biopharmaltd.com or by Telephone at: +254 726 999 888
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:
- 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 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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Medicine Quality Alert: Class II Medicine Recall of Steramine (Betamethasone and Dexchlorpheniramine) Tablets Batch No. BPL783A and BPL409A