DRAP Recalls:
Substandard Medicine : Famobex Suspension by Cibex (Pvt.) Ltd.
The Drug Regulatory Authority of Pakistan (DRAP) has issued a recall alert for a substandard batch of Famobex Suspension (Batch No. 5330) manufactured by M/s. Cibex (Pvt.) Ltd., F-405, S.I.T.E, Karachi.
š¬ Reason for DRAP Recall:
The sample from Batch No. 5330 of Famobex Suspension has been declared to be substandard as it fail “Assay testing” conducted by the Central Drug Laboratory (CDL), Karachi.
š¦ Product Details:
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Product Name: Famobex Suspension
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Composition: Each 5ml contains Famotidine 10mg
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Batch No.: 5330
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Manufacturer: M/s. Cibex (Pvt.) Ltd., F-405, S.I.T.E Karachi
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Therapeutic Category: Gastrointestinal
ā ļø Risk Summary:
Use of substandard medicine may lead to serious health risks, especially in pediatric or immunocompromised patients.
š¢ Action Required for DRAP recall by Healthcare Professionals:
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All pharmacists & chemists working at distributors and pharmacies should immediately check their stocks and stop supplying this suspension. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.
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Consumers are advised to stop using Famobex suspension bearing the affected batch number 5330. They shall contact their doctor if they have experienced any adverse effect that may be related to using this suspension.
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Report adverse events or quality concerns to DRAP via Vigimobile App:
Reference:
Drug Regulatory Authority of Pakistan. (2025, June). Recall alert: Recall of substandard Famobex Suspension (Batch No. 5330) manufactured by M/s. Cibex (Pvt.) Ltd., Karachi. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-recall-of-substandard-famobex-suspension-batch-no-5330-manufactured-by-m-s-cibex-pvt-ltd-karachi/
