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Month: April 2025

Rapid Alert: PRESENCE OF FALSIFIED INJECTION RHOPHYLAC 300MCG, HUMAN ANTI-D IMMUNOGLOBULIN PURPORTEDLY MANUFACTURED BY M/S. CSL BEHRING AG, SWITZERLAND

Ahsan Hafiz Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/04-25-38
Action Date30th April, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDirectorate of Drugs Control Punjab (DDCP), vide Alert No. 169/2025, has notified DRAP regarding the presence of falsified Rhophylac 300mcg Injection in the market across Pakistan. Details of the identified product are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoPurported ManufacturerRemarks
Injection Rhophylac 300, Human Anti-D ImmunoglobulinP100669751M/s CSL Behring Switzerland, Wankdorfstrasse 10, CH-3000 Bern 22,Switzerland.‘Spurious’ as per Drugs Act 1976, section 3(z-b) (ii) and ‘Substandard’ on the basis of sterility test.

Risk StatementThe Anti-D immunoglobulin is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown.
Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified products. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

Recall Alert: SUBSTANDARD PRODUCTS DECLARED BY DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/04-25-37
Action Date22nd April, 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured byTest Results
Omsana-AM Tablet

 
Reg. No. 058557		Each film coated tablet contains:
Amlodipine (as besylate).…5mg
Olmesartan Medoxomil….20mg		155367M/s Hilton Pharma (Pvt) Ltd,
Plot No. 13-14, Sector-15, Korangi Industrial Area, Karachi.		‘Substandard’ on the basis of Test for Impurities (Organic impurities).
BYTEC Tablet

 
Reg. No. 036183		Each film coated tablet contains:
Cetirizine dihydrochloride.…10mg		E605M/s. Batala Pharmaceuticals,
23/B, Small Industrial Estate # 2, Gujranwala.		‘Adulterated’ as defined under clause (iv) of sub-section (a) of section 3 of Drugs Act, 1976.
Myteka Sachet

 
Reg. No. 039695		Each sachet contains:
Montelukast sodium eq. to Montelukast…..4mg		155384M/s Hilton Pharma (Pvt) Ltd,
Plot No. 13-14, Sector-15, Korangi Industrial Area, Karachi.		‘Substandard’ on the basis of Assay Test & Test for Impurities (Organic impurities). 
Isanex 1g Injection


Reg. No. 024657		Each vial contains:
Ceftriaxone sodium eq. to ceftriaxone…1g		IA-703M/s Humayun International Pharma (Pvt) Ltd.,
20-Km, Satiana Road, Faisalabad.  		‘Substandard’ on the basis of Sterility test & Bacterial Endotoxin Test
Medi-Lox Tablet

Reg. No.  056133		Each film coated tablet contains:
Ciprofloxacin as HCl….250mg		425M/s Medicon Pharmaceutical Industries (Pvt) Ltd.,
B-1/11, Industrial Estate, Hyatabad, Peshawar.		‘Substandard’ on the basis ofDissolution Test.
Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.
– All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. 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.

–Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk.

–Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.