Medicine Quality Alert: Class III Recall of Famcal tablets, Batch No FDF1AD3B
Sai Pharmaceuticals (Kenya) Limited has initiated an urgent recall of batch FDF1AD3B for Famcal tablets (Calcium citrate malate 250mg; cholecalciferol 100 i.u).
From: Pharmacy and Poisons Board
Published: 14th December 2022
Recall Reference Number: REC/2022/11
Recall Classification: Class III
Recall Level: Wholesale/Distributor Level
Manufacturer: Indoco Remedies Limited, India
Local Technical Representative: Sai Pharmaceuticals (Kenya) Limited
Product name: Famcal tablets
Active Pharmaceutical Ingredient: Calcium citrate malate 250mg; cholecalciferol 100 i.u
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
FDF1AD3B | 01.2022 | 12.2023 | 30’s |
Brief description of the problem
Sai Pharmaceuticals (Kenya) Limited is recalling batch FDF1AD3B Famcal tablets (Calcium citrate malate 250mg; cholecalciferol 100 i.u) due to out-of-specification results on assay test of cholecalciferol during the review of stability results.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing, or use of batch FDF1AD3B and immediately return to the supplier.
Action for patients and caregivers
No further action is required by patients as this is a Wholesaler/Distributor level recall. The patients should continue taking other batches of the product other than the impacted batches and as prescribed by the healthcare professional.
Further Information
For any Famcal stock enquiries please contact Sai Pharmaceuticals (Kenya) Limited via email at Head-regulatory@saipharm.com or via telephone at +254 731 952 330
You are encouraged to promptly report any case/s of suspected substandard and falsified product or adverse reactions or insufficient control of symptoms to the nearest healthcare facility or the Pharmacy and Poisons Board 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 contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@pppb.go.ke
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Medicine Quality Alert: Class III Recall of Famcal tablets, Batch No FDF1AD3B