49. Rapid Alert: SPURIOUS/FALSIFIED RHOPHYLAC 300 INJECITION (BATCH NUMBER P100830101)
Rapid Alert
| SPURIOUS/FALSIFIED RHOPHYLAC 300 INJECITION (BATCH NUMBER P100830101) |
| DRAP Alert No | No I/S/11-02-49 |
| Action Date | 2nd November, 2026 |
| Target Audience | Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers |
| Problem Statement | Marketing Authorization Holder (MAH) of the below mentioned product i.e. M/S Hakimsons (Impex) (pvt.) Ltd., Karachi in response to the letter from provincial inspector of drugs, KPK has informed that Batch No. P100830101 of Rhophylac 300 injection available in the market is not associated with their company and does not belong to their authorized product distribution and hence is Spurious as per Section 3(z)(b)(ii) of the Drugs Act, 1976. |
| Sr. No. | Name of Product | Batch number | Name of Manufacturer | Remarks |
| 1 | Rhophylac 300 Injection Solution for Injection is pre-filled syringe | P100830101 | Purported to be manufactured by: M/s CSL Behring AG, Switzerland | The authorized supplier has informed that Batch number P100830101 is not associated with their company. |
| Risk Statement | The use of above-mentioned Spurious/Falsified drug product i.e. Rhophylac 300 InjecitonVaccine (Batch # P100830101) may pose serious safety and quality concerns for Public Health as administration of a Spurious/Falsified drug product may fail to provide intended response in the body and could expose recipients to unknown safety risks. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments have been asked to conduct surveillance activities throughout the supply chain to confiscate the falsified product. |
| Advice for Healthcare Professionals | DRAP 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 Consumers | Consumers should not use the above-mentioned product 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. |
Career Opportunities(Balochitan Quota)
48. Rapid Alert: Spurious/Falsified INFLUVAC TETRA VACCINE (BATCH # P13)
Rapid Alert
| Spurious/Falsified INFLUVAC TETRA VACCINE (BATCH # P13) |
| DRAP Alert No | No I/S/10-30-48 |
| Action Date | 30th October, 2026 |
| Target Audience | Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers |
| Problem Statement | Provincial Inspector of Drugs, Lahore has registered a case regarding the alleged supply of Spurious/Falsified Influvac Tetra Vaccine. Verification from the authorized supplier confirmed that Batch No. P13 was Spurious/Falsified and not part of the legitimate supply chain. The detection and recovery of a spurious Influvac Tetra Vaccine (Batch No. P13) being marketed and supplied through online channels presents a significant public health risk, as administration of a falsified vaccine may fail to provide the intended immunological protection and could expose recipients to unknown safety risks. Following are the details: |
| Sr. No. | Name of Product | Batch number | Name of Manufacturer | Remarks |
| 1 | Influvac Tetra Vaccine | P13 | Purported to be manufactured by: M/s Abbott Biologicals B.V., the Netherlands | The suspected batch i.e. P13 is found to be Spurious/Falsified. |
| Risk Statement | The use of above-mentioned Spurious/Falsified Vaccine i.e. Influvac Tetra Vacine (Batch # P13) may pose serious safety and quality concerns for Public Health as administration of a Spurious/Falsified vaccine may fail to provide the intended immunological protection and could expose recipients to unknown safety risks. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments have been asked to conduct surveillance activities throughout the supply chain to confiscate the falsified product. |
| Advice for Healthcare Professionals | DRAP 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 Consumers | Consumers should not use the above-mentioned product 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. |
Guidelines on Establishment of Pharmaceutical Unit, Grant And Renewal of Drug Manufacturing License thereof
S.R.O. 1915(I)/2026, Notification of Amendments in the Drugs (Research) Rules 1978 (28.10.2026)
47. Rapid Alert: Falsified INFLUENZA VACCINE VAXIGRIP TETRA (BATCH # Y4B34)
Rapid Alert
| Falsified INFLUENZA VACCINE VAXIGRIP TETRA (BATCH # Y4B34) |
| DRAP Alert No | No I/S/10-26-47 |
| Action Date | 27th October, 2026 |
| Target Audience | Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers |
| Problem Statement | M/s Hoechst Pakistan Limited, Plot No. 23, Sector 22, Korangi Industrial Area, Karachi has informed that a Falsified drug product i.e. Vaxigrip Tetra, Quadrivalent Influenza Vaccine (Batch No. Y4B34) has been found to be available in the market. |
| Sr. No. | Name of Product | Batch number | Name of Manufacturer | Remarks |
| 1 | Vaxigrip Tetra Vaccine (Suspension for Injection in Pre-filled Syringe) | Y4B34 | Purported to be manufactured by: M/s Sanofi Winthrop Industrie, France | The suspected batch i.e. Y4B34 has never been imported or distributed in Pakistan. |
| Risk Statement | The use of above-mentioned Falsified Vaccine i.e. Vaxigrip Tetra (Batch # Y4B34) may pose serious safety and quality concerns for Public Health |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments have been asked to conduct surveillance activities throughout the supply chain to confiscate the falsified product. |
| Advice for Healthcare Professionals | DRAP 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 Consumers | Consumers should not use the above-mentioned product 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. |
46. Recall Alert: Substandard Cikina Umblical Cord Clamp
Recall Alert
| MEDICAL DEVICES DECLARED (CIKINA UMBLICAL CORD CLAMP SUBSTANDARD BY DRUG TESTING LABORATORY PUNJAB, Rawalpindi |
| DRAP Alert No | No I/S/10-26-46 |
| Action Date | 27 October, 2026 |
| Target Audience | – National Regulatory Field Force – Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals – General Public |
| Problem / Issue | Drug Testing Laboratory Punjab, Rawalpindi has informed Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical device have been declared “Substandard” on the basis of Sterility Testing. |
| Sr. No. | Product Name | Name of Manufacturer/Importer | Batch Number | Remarks |
| 1 | CIKINA UMBILICAL CORD CLAMP (UMBILICAL CORD CLAMP) MDIR: 0003486 | M/s Ningbo Greatcare Trading Co. Ltd, China; Marketed by: Al-Hamd Enterprises, FL-11/1/1, Block 6, Gulshan e Iqbal Karachi Karachi (ELI # 00285) | 25495 | The sample is SUBSTANDARD on the basis of Sterility test. |
Therapeutic Goods (s) Affected: –
| Risk Statement: | The sterility failure of the umbilical cord clamp may result in exposure of neonatal patients to microbial contamination. Due to the vulnerable patient population, inability of the user to detect the defect, and potential for serious infection including sepsis, the residual risk is considered unacceptable and requires immediate corrective and regulatory action. |
| Action Initiated | The field force of DRAP and Provincial Drug Control Departments have been asked to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for Pharmacies/Medical stores: – | All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products. |
| Advice for Consumers | Consumers and healthcare facilities in possession of the affected batches should immediately stop using the above-mentioned products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre. |
45. Recall Alert (Carapamin Injection & Librax Tablet/Dragees)
Recall Alert
| DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB |
| DRAP Alert No | No I/S/10-26-45 |
| Action Date | 23rd October, 2026 |
| Target Audience | – – National Regulatory Field Force – Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals – General Public |
| Problem / Issue | Drug Testing Laboratory (DTL), Punjab has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned drug products have been declared “Substandard” on the basis of Sterility Testing. |
| Sr. No. | Name of product | Batch Number | Name of Manufacturer | Remarks |
| 1 | Carapamin Injection 200mg (Dopamine HydrochlorideUSP) Reg. No. 060235 | 26A059 | M/s Caraway Pharmaceuticals, plot # 12, St. N-3, National Industrial Zone (RCCI) Rawat, Islamabad (DML # 000629) | The sample is declared as Substandard on the basis of content of organic impurities found above the allowed limits by DTL Punjab, Lahore. |
| 2 | Librax Tablet (Chlordiazepoxide USP 5mg & Clinidium Bromide USP 2.5mg) Reg # 000568 | 001952 | M/s Martin Dow Limited, plot # 37. Sector 19, Korangi Industrial Area, Karachi. (DML # 000267) | The sample is declared as Substandard on the basis of content of organic impurities found above the allowed limits by DTL Punjab, Faisalabad. |
Therapeutic Goods (s) Affected: –
| Risk Statement: | These products present a moderate to high public health risk, mainly affecting the general population, especially cardiac patients, allergy sufferers, children, and chronic medicine users. Moreover, the impurities may alter the stability of drug products and may cause formation of new complexes. |
| Action Initiated | The Provincial Drug Control departments and DRAP’s field offices have been asked to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above-mentioned products are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for Pharmacies/Medical stores: – | All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). |
| Advice for Consumers | Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre. |
44. Rapid Alert: Spurious/Falsified BREXIN TABLET
Rapid Alert
| Spurious/Falsified Drug product (Brexin Tablet) |
| DRAP Alert No | No I/S/10-26-44 |
| Action Date | 22nd October, 2026 |
| Target Audience | Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers |
| Problem Statement | Drug Testing Laboratory (DTL) Sindh, Karachi declared the following sample as Spurious/Falsified under Section 3(z-b) (ii) & 3(z-b) (i) of the Drugs Act, 1976. The sample was referred to DTL Sindh, Karachi, by the Area Provincial Inspector of Drugs, Karachi. The manufacturer has disowned the sample. |
| Sr. No. | Name of Product | Batch number | Name of Manufacturer | Remarks |
| 1 | Brexin Tablet | W68C | Purported to be manufactured by: M/s Glaxo Smith Kline Pakistan Ltd, F/268 SITE Karachi Under license of M/s Chiesi Farmaceutici S.p.A Pharma Italy. | The sample is declared as “Spurious” since it does not contain the active ingredient i.e. Piroxicam B-Cyclodextrin. |
| Risk Statement | Use of the above-mentioned products may result in treatment failure due to the absence of the declared active ingredient and may pose potential risks to patient safety. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments have been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| Advice for Healthcare Professionals | DRAP 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 Consumers | Consumers 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. |