Month: March 2026
14. Recall Alert (Human) – DTLs Punjab Declared substandard drug products.
Recall Alert
| DRUG PRODUCT DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB. |
| DRAP Alert No | No II/S/03-26-14 |
| Action Date | 11 March, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard ’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Medizole Suspension 60m1 Each 5 ml contains metronidazole….40 mg Furazolidone….25 mg (Reg # 005721) | SR260004 | M/s Medicon Pharmaceutical Industries (Pvt) Ltd. 11 Industrial Estate Hayatabad Peshawar (DML # 000215) | The sample is “Substandard” on the basis of pH test performed. |
| 2. | Sachet PURGO 4mg Each sachet contains: Montelukast Sodium eq. to Montelukast …….4mg (Reg # 076497) | 055 | M/s Hiranis Pharmaceuticals (Pvt) Ltd. Plot No. E-145 to E-149 North Western Industrial Zone Port Qasim, Karachi. | The sample is “Substandard” on the basis of impurities test. |
| 3. | Sachet G-Mont Each sachet contains: Montelukast Sodium eq. to Montelukast …….4mg (Reg # 080691) | GMT108 | M/s GT Pharma (Pvt) Ltd. 713 Sundar Industrial Estate Lahore. (DML # 000829) | The sample is “Substandard” on the basis of impurities test. |
| Risk Statement: | The above-mentioned products have been declared Substandard based on laboratory testing (pH and impurities failure). Substandard medicines may result in reduced therapeutic effectiveness, delayed recovery, or unexpected adverse reactions. Children suffering from diarrhea and gastrointestinal infections (Medizole Suspension) and pediatric patients using Montelukast sachets for asthma or allergic conditions are most likely to be affected. Treatment failure in these populations may lead to worsening of symptoms, increased risk of complications, and unnecessary escalation of therapy. |
| 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 returned to the supplier/company. –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 Professionals | DRAP 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. |
Minutes of the 121st and 122nd meetings of the Medical Devices Board (MDB)
13. Rapid Alert – SPURIOUS TABLET D-GEST DYDROGESTERONE 10 mg) (BATCH NO. DGH007)
Rapid Alert
| SPURIOUS TABLET D-GEST DYDROGESTERONE 10 mg) (BATCH NO. DGH007) |
| DRAP Alert No | No I/S/03-26-13 |
| Action Date | 11 March, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug Testing Laboratory (DTL), Punjab vide Test Report No. 01-10096006005/DTL dated 21-02-2026 has declared Tablet D-Gest (Dydrogesterone 10 mg), labeled as manufactured by M/s Pharma Health Pakistan (Pvt.) Ltd., 17-Km Ferozepur Road, Lahore, as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976, as laboratory analysis revealed that Dydrogesterone was not identified by FTIR and assay testing showed 0.0 mg per tablet against the labeled claim of 10 mg (specification limit 90–110%), indicating complete absence of the declared active pharmaceutical ingredient. |
| S# | Product Name | Batch | Manufacturer | Test Result |
| 1 | Tablet D-Gest (Dydrogesterone 10 mg) | DGH007 | M/s Pharma Health Pakistan (Pvt) Ltd. 17-Km Ferozepur Road Lahore (DML # 000761) | Declared Spurious (API absent) |
| Risk Statement | Dydrogesterone is indicated for management of progesterone deficiency conditions including threatened miscarriage, menstrual disorders, and luteal phase support. Laboratory findings confirmed complete absence of the active ingredient, resulting in total therapeutic failure. Use of such product may lead to serious clinical consequences including pregnancy loss, hormonal imbalance, and failure of prescribed treatment. The public health risk is assessed as high, particularly in pregnant women and hormone-dependent patients. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has 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. |
12. Rapid Alert – SPURIOUS CAPSULE GABICA 300 mg (BATCH NO. 518C27)
Rapid Alert
| SPURIOUS CAPSULE GABICA 300 mg (BATCH NO. 518C27) |
| DRAP Alert No | No I/S/03-26-12 |
| Action Date | 11 March, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug Testing Laboratory (DTL), Punjab vide Test Report No. 01-105013280/DTL dated 23-02-2026 has declared the following sample of product as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976. The product is purported to be manufactured by M/s Getz Pharma (Pvt.) Limited, Karachi, Pakistan. However, the manufacturer has officially disowned the recovered sample and confirmed that the sealed sample has neither been manufactured nor sold by them. The firm has categorically declared the product counterfeit after physical comparison with their retention sample. |
| S# | Product Name | Batch | Manufacturer (as per label) | Test Result |
| 1 | Capsule Gabica 300 mg Each Capsule contains: Pregabalin 300 mg | 518C27 | Purported to be manufactured by M/s Getz Pharma (Pvt.) Limited, 29-30/27, K.I.A., Karachi, Pakistan | Declared Spurious |
| Risk Statement | Gabica (Pregabalin) 300 mg is indicated for neuropathic pain, epilepsy, and generalized anxiety disorders. Although laboratory testing showed compliance in assay and dissolution parameters, the manufacturer has confirmed that the recovered batch is counterfeit and not produced or marketed by them. Use of falsified pregabalin capsules may result in therapeutic inconsistency, treatment failure, or exposure to unknown manufacturing conditions. The circulation of counterfeit medicines poses a significant public health concern due to lack of regulatory oversight and quality assurance. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has 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. |
11. Rapid Alert – SPURIOUS & SUBSTANDARD INJECTION VENOFER 5 mL (Batch No. 4721026AA)
Rapid Alert
| SPURIOUS & SUBSTANDARD INJECTION VENOFER 5 mL (Batch No. 4721026AA) |
| DRAP Alert No | No I/S/03-26-11 |
| Action Date | 11 March, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug Testing Laboratory (DTL), Punjab has declared the following sample of product as Spurious under Section 3(zb)(ii), Misbranded under Section 3(s)(vi), and Substandard under the Drugs Act, 1976. |
| S# | Product Name | Batch No. | Manufacturer (as per label) | Test Result |
| 1 | Injection Venofer 5 mL (Iron Sucrose 100 mg/5 mL) | 4721026AA | Purported to be manufactured by Takeda Austria GmbH, Austria Imported by: M/s Searle Pakistan Limited | Declared Spurious, Misbranded & Substandard (Assay failure of Iron & Sucrose) |
The product is purported to be manufactured by Takeda Austria GmbH, Austria and imported by M/s Searle Pakistan Limited. However, the authorized importer has officially disowned the recovered sample and confirmed, after physical comparison with their retention sample of the same batch, that the provided sample is counterfeit.
Laboratory analysis revealed failure of assay for Iron and Sucrose contents, while sterility test complied. The product also does not contain finished drug product specifications.
| Risk Statement | The product is a Human Anti-D (Rh) Immunoglobulin injection indicated for prevention of Rh isoimmunization in Rh-negative individuals. Laboratory testing revealed microbial growth in sterility testing, indicating contamination and rendering the product unsafe for parenteral administration. Additionally, the batch has been confirmed as falsified and not legally imported by the authorized distributor. Administration of this contaminated and spurious biological product may lead to serious bloodstream infections, therapeutic failure in prevention of Rh sensitization, and life-threatening complications. The public health risk is assessed as high, particularly for pregnant women and immunocompromised patients. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has 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. |
10. Rapid Alert – Spurious Injection RHOPHYLAC 300 µg (Batch # P100707423)
Rapid Alert
| SPURIOUS INJECTION RHOPHYLAC 300 µg (BATCH NO. P100707423) |
| DRAP Alert No | No I/S/03-26-10 |
| Action Date | 11 March, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug Testing Laboratory (DTL), Punjab vide Test Report No. 01-105012931/DTL dated 06-02-2026 has declared the following sample as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976. The product is purported to be manufactured by M/s CSL Behring AG, Switzerland and imported/distributed by M/s Hakimsons (Impex) (Pvt.) Ltd., Karachi; however, verification from the stated importer confirms that the recovered batch does not belong to them and was not legally imported. The sample also failed Sterility Test (Membrane Filtration Method) and was additionally categorized as Substandard on sterility grounds and Misbranded with respect to labeling. |
| S# | Product Name | Batch No. | Manufacturer (as per label) | Test Result |
| 1 | Injection Rhophylac 300 µg (Human Anti-D (Rh) Immunoglobulin) Prefilled Syringe 2 ml (1500 IU / 300 µg) | P100707423 | Purported to be manufactured by: M/s CSL Behring AG, Switzerland Imported/Distributed by: M/s Hakimsons (Impex) (Pvt.) Ltd., Karachi | Declared Spurious, Misbranded & Substandard (Sterility Failure) |
| Risk Statement | The product is a Human Anti-D (Rh) Immunoglobulin injection indicated for prevention of Rh isoimmunization in Rh-negative individuals. Laboratory testing revealed microbial growth in sterility testing, indicating contamination and rendering the product unsafe for parenteral administration. Additionally, the batch has been confirmed as falsified and not legally imported by the authorized distributor. Administration of this contaminated and spurious biological product may lead to serious bloodstream infections, therapeutic failure in prevention of Rh sensitization, and life-threatening complications. The public health risk is assessed as high, particularly for pregnant women and immunocompromised patients. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has 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. |
09. Rapid Alert – SPURIOUS CEFIXIME 400mg CAPSULE (Batch # LLM034)
Rapid Alert
| SPURIOUS CEFIXIME 400 mg CAPSULE (BATCH NO. LLM034) |
| DRAP Alert No | No I/S/03-26-09 |
| Action Date | 11 March, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug Testing Laboratory (DTL), Punjab has declared following sample of product as ‘Spurious’ purported to be manufactured/marketed by the stated manufacturer, however, upon laboratory analysis and comparison with the genuine QC retention sample, it has been determined that the product is not the authentic product of the registered manufacturer and is therefore classified as spurious under the Drugs Act, 1976. |
Following product is being marketed and sold in Pakistan without prior registration/enlistment with the Drug Regulatory Authority of Pakistan (DRAP)
| S# | Product Name | Batch | Manufacturer | Test Result |
| 1 | Capsule CARICEF Cefixime Trihydrate equivalent to Cefixime …………400 mg (Reg # 022416) | LLM034 | Purported to be manufactured by: M/s Healthtek (Pvt.) Ltd., Plot No. 14, Sector 19, Korangi Industrial Area, Karachi Marketer SAMI Pharmaceuticals (Pvt.) Ltd., F-95, S.I.T.E., Karachi | Declared Spurious |
| Risk Statement | The subject product has been declared Spurious, as laboratory analysis confirmed absence of the stated active ingredient (Cefixime), resulting in complete therapeutic failure. Packaging comparison with the genuine manufacturer’s QC retention sample revealed significant discrepancies in printing, hologram security features, blister demarcation, and labeling details, confirming it is not an authentic product. Use of this falsified antibiotic may lead to disease progression, complications, and increased antimicrobial resistance. The risk to public health is assessed as high, particularly for patients requiring effective antibacterial therapy. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has 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. |
08. Recall Alert (Class-II) – DTLs punjab declared substandard drug products.
Recall Alert
| DRUG PRODUCT DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB. |
| DRAP Alert No | No II/S/03-26-08 |
| Action Date | 11 March, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard ’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Tablet Sapizine 10 mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 054261) | 13208 | M/s Sapient Pharma. 123-S Industrial Area Kot Lakhpat Lahore. (DML # 000207) | The sample has been declared “substandard” on the basis of organic impurities. |
| Risk Statement: | Tablet Sapizine 10 mg (Cetirizine Dihydrochloride 10 mg) has been declared sub-standard due to the presence of organic impurities beyond acceptable pharmacopeial limits. Elevated organic impurities may indicate degradation, poor manufacturing control, or inadequate storage conditions, potentially leading to reduced potency, altered pharmacological effect, or increased risk of adverse reactions such as hypersensitivity or gastrointestinal disturbances. The population most likely to be affected includes general out-patient users, particularly children, elderly patients, and individuals with allergic rhinitis, urticaria, or other hypersensitivity conditions relying on consistent antihistaminic therapy. Although cetirizine is not a life-saving drug, compromised quality may result in therapeutic failure and unnecessary exposure to impurities. |
| 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 returned to the supplier/company. –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 Professionals | DRAP 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. |
07. Recall Alert (Human) – DTLs Punjab declared substandard drug products.
Recall Alert
| DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB. |
| DRAP Alert No | No I/S/03-26-07 |
| Action Date | 11 March, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard & Adulterated’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Injection SORIDE Each mL contains: Sodium Chloride USP….9mg (Reg # 044017) | SR260004 | M/s Bosch Pharmaceuticals (Pvt) Ltd. 221 Bosch House Sector 23 Korangi industrial Area Karachi. (DML # 000350) | The sample is declared as “Misbranded” under Section 3(s)(iv) of the Drugs Act, 1976 due to non-compliance with USP labelling requirements (osmolar concentration not stated on the label as required). The sample is also declared “Sub-Standard” on the basis of visible particulates in injection. |
| 2. | Injection Neudex Each ml contains: Dexamethasone sodium phosphate eq. to dexamethasone phosphate……4mg (Reg # 042943) | DX030 | M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576) | The above sample is Adulterated as per The Drugs Act 1976, 3 (a)(iv) on the basis of Identification and Quantification of Dexamethasone (base). |
| Risk Statement: | The cited products, Injection SORIDE (Sodium Chloride 0.9%) and Injection Neudex (Dexamethasone Sodium Phosphate 4 mg/mL), present significant clinical and regulatory risk. SORIDE has been declared misbranded due to non-compliance with USP labeling requirements (absence of osmolar concentration), which may lead to improper clinical use in sensitive populations such as neonates, critically ill, or electrolyte-imbalanced patients. More critically, the presence of visible particulates in a parenteral preparation classifies it as sub-standard, posing a direct risk of embolism, phlebitis, pyrogenic reactions, and systemic inflammatory responses. Injection Neudex has been declared adulterated based on failure in identification and quantification of dexamethasone (base), indicating potential presence of incorrect strength, substitution, or degradation. This may result in therapeutic failure in emergency conditions such as anaphylaxis, cerebral edema, severe asthma, or shock, where corticosteroids are life-saving. The population most likely to be affected includes hospitalized patients, emergency cases, pediatric and ICU patients receiving IV fluids or corticosteroid injections. The overall risk level is assessed as high, particularly because both products are injectable formulations administered systemically, and any quality defect may result in immediate and serious patient harm. |
| 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 returned to the supplier/company. –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 Professionals | DRAP 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. |