Medicine Quality Alert: Class II Recall of Papazyme (Papain, Fungal Diastase, and Simethicone) Tablets, Batch No. P1024042
Micro Labs (EA) Ltd has initiated a voluntary recall of Papazyme (Papain, Fungal Diastase, and Simethicone) Tablets, Batch No. P1024042, manufactured by Gelpach International, India
From: Pharmacy and Poisons Board
Date of Recall Initiation: 02/12/2025
Recall Reference Number: REC/2025/036
Recall Classification: Class II
Recall Level: Retail/Facility level
Local Technical Representative: Micro Labs (EA) Ltd
Manufacturer: Gelpach International, India
Product name: Papazyme
Active Pharmaceutical Ingredient: Papain, Fungal Diastase, and Simethicone
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
P1024042 | 06/2024 | 05/2027 | 2 x 4’s |
Brief description of the problem
The product is being recalled due to an observed issue of bulging strip packs.
Action for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Micro Labs (EA) Limited or Laborex Kenya to arrange the return.
Action for patients and carers
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 batch of Papazyme Tablets.
Further Information
For inquiries about consignments of the impacted batch, please contact Micro Labs (EA) Limited and Laborex Kenya by email at: regulatoryeastafrica@microlabs.africa and ssavla@laborex-healthcare.com or by Telephone at +254 113 213 203, +254 (0) 20 69 39 162 or +254 769 579 060.
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 Recall of Papazyme (Papain, Fungal Diastase, and Simethicone) Tablets, Batch No. P1024042