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Recall Alert: Substandard Nocox Tablets Batch No. 8463 Manufactured by M/s. Alfalah Pharma (Pvt.) Ltd., 12-Km Lahore Road, Jamal Park, Sheikhupura
Recall Alert
| DRAP Alert No | No I/S/12-24-54 |
| Action Date | 12th December, 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | Federal Government Analyst, CDL Karachi vide test report No. LHR-10-24-000007 has declared the subject mentioned batch of product Nocox tablet as of substandard quality. Details of CDL test report are as under |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Nocox Tablet (Reg# 052499) | Meloxicam 15mg | Batch no. 8463 Mfg date: 02/2024 Expiry date: 02/2026 | M/s. Alfalah Pharma (Pvt.) Ltd., 12-km Lahore Rd, Jamal Park, Sheikhupura |
| Risk Statement: | Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk. |
| Action Initiated | -The regulatory field force of DRAP and Provincial Drug Control departments have 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 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. |
Rapid Alert: Contaminated Propylene Glycol (Batch # YF01210911) Allegedly Manufactured by M/S. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.
Rapid Alert
| DRAP Alert No | No I/S/12-24-52 |
| Action Date | 12th December, 2024 |
| Target Audience | 1. Regulatory Field Force. 2. Therapeutic Goods industry 3. Manufactures of Oral liquid preparations 4. Healthcare professionals |
| Problem Statement | Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. RM-10-24-000624 dated 19-11-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by a licensed pharmaceutical manufacturer in compliance to advisory issued by DRAP vide No. 03-41/2023-QC dated 01-12-2023. The supply chain of this raw material is still under investigation. Details of test/analysis report are given as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| Propylene Glycol (Raw material) | YF01210911 | 22-May-2023 | 21-May-2025 | M/s. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.[The material found in the packaging with the label of this manufacturer, however product authenticity and supply chain integrity are under investigation and yet not confirmed.] | The sample is declared substandard due to conatmination of Ethylene Glycol. |
| Risk Statement | Di-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences. |
| Action Initiated | The Regulatory Field Force has directed to take increase surveillance for identification of above mentioned contaminated batch of Propylene Glycol in the market and is investigating the entire supply chain of this batch. The Regulatory Field Force has also been instructed to seize all oral preparations manufactured using the same batch of propylene glycol if found in the market. |
| Advice for Therapeutic Goods Manufacturers | Manufacturers of therapeutic goods are required to follow these instructions: 1. Recall Products: If any batch was manufactured using the same lot of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled. 2. Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain. 3. Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. 4. Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. 5. Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and 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. |
Rapid Alert : Falsified Product Askinoren Gel (Azelaic Acid 15%) Purportedly Manufactured By M/s. Medshare Pharma Risalpur, Kpk
Rapid Alert
| DRAP Alert No | No I/S/12-24-56 |
| Action Date | 10rd December, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public |
| Problem Statement | The firm M/s OBS Pharma (Pvt.) Limited, Karachi, has notified DRAP regarding the presence of falsified product “Askinoren Gel” in the market across Pakistan. The primary packaging of the product shows no Batch number and Expiry date. Also, a different brand name Acnoren was mentioned under the heading of dosage. Moreover, there was no Urdu instruction and dosage required as per Labelling Rules, 1986. The details of the identified product are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label claim) | Lab Test Results |
| 1 | Askinoren Gel | Azelaic Acid 15%) | Nil | M/s Medshare Pharma, Plot No. 04, Special Industrial Zone (APO) Risalpur, KPK. | Spurious |
| Risk Statement: | Azelaic acid is used for the treatment of skin pigmentation and acne. Falsified product may pose a significant threat to public health as the safety and efficacy of such products cannot be established. |
| Action Initiated | The Regulatory Field Force has been directed to take necessary action on the above-mentioned falsified product and is investigating the entire supply chain of this product. The Regulatory Field Force has also been instructed to seize identified falsified products if found on the market. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available at this link. Any adverse events or quality problems experienced with the use of these products should be reported to the 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 Consumer | 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 these 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.
Rapid Alert: Falsified Dayquil Kids (Vicks) Berry Cold & Cough + Mucus Purportedly Manufactured By M/S. Procter & Gamble, Cincinnati, OH 45202.
Rapid Alert
| DRAP Alert No | No I/S/12-24-51 |
| Action Date | 03rd December, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public |
| Problem Statement | Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. KQ-7-24-000112 dated 15-10-2024 declared the sample of DayQuil Kids (Vicks) as unregistered (Falsified) Drug. The product contains Dextromethorphan HBr which is an allopathic drug, therefore, the said product must be registered with DRAP. The details of the product are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label claim) | Lab Test Results |
| 1 | DayQuil Kids (Vicks) Berry Cold & Cough + Mucus | Nil | 31254334L4 | Purported to be manufactured by M/S.PROCTER & GAMBLE, CINCINNATI, OH 45202 | Spurious |
| Risk Statement: | DayQuil Kids (Vicks) is a widely available over-the-counter (OTC) medication for cough and flu relief. However, its active ingredient, Dextromethorphan HBr, may pose potential health risks, necessitating regulatory oversight to ensure safe consumption. |
| Action Initiated | The Regulatory Field Force has been directed to take necessary action on the above-mentioned falsified product and is investigating the entire supply chain of this product. The Regulatory Field Force has also been instructed to seize identified falsified products if found on the market. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available at this link. Any adverse events or quality problems experienced with the use of these products should be reported to the 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 Consumer | 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 these 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: Recall Notices for 7 products Issued By Provincial Drug Testing Laboratories
Recall Alert
| DRAP Alert No | No I/S/11-24-50 |
| Action Date | 29th November, 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | TDDCP PV Lahore and Secretary PQCB Quetta has informed DRAP regarding recall of following batches of mentioned products: |
Therapeutic Good(s) Affected: –
| Sr.No. | Product Names | Composition | Manufactured by | Test Results |
| 1. | Infusion Zeesol-5 1000 mL Reg# 016611 | Dextrose Anhydrous 50 g/ 1000mL | Shazeb Pharmaceutical Industries Limited Hazara Trunk Road, Sarai Gadaee, District Haripur, K.P.K Pakistan | Substandard on the basis of Bacterial Endotoxin |
| 2. | Sterile Water for Injection 5 mL Reg# 062671 | Sterile Water for Injection | Fynk Pharmaceuticals 19-KM. G.T. Road, Kalashah Kaku, Lahore | Substandard” on the basis of Visible Particulates in Injections |
| 3. | Infusion Cyanoco (Vitamin B12) 100mL Reg# 041241 | Cyanocobalamin 500 mcg/2mL | International Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna Lahore | Adulterated |
| 4. | Infusion Cyanoco Super 100mL Reg# 041242 | Cyanocobalamin 1000 mcg/2mL | International Pharma Labs Raiwind Road Bhobatian Chowk, Defence Road, 1-KM, towards Kahna Lahore | Adulterated |
| 5. | Syrup Desora Reg# 055192 | Desloratadine 0.5mg/mL | S.J. & G. Fazul Ellahie (PVT) Ltd., E-46, S.I.T.E., Karachi | Ethylene Glycol above the permissible limit |
| 6. | Inj. Isanex Reg# 024657 | Sterile Powder of Ceftriaxone Sodium eq. to Ceftriaxone 1g/Vial | Humayun International Pharma (PVT) LTD 20-km, Satiana Road, Faisalabad | “Substandard” with regards to Sterility Test |
| 7. | EmpLiMet XR tablet Reg# 121679 | Empaglifozin, Linagliptin, Metformic HCl | Horizon Healthcare (Pvt.) Ltd., Plot no. 33, sundar Industrial estate, Lahore | Substandard on the basis of Assay |
| Action Initiated | -The regulatory field force of DRAP and Provincial Drug Control departments have 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 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. |
Rapid Alert: Crackdown Against Falsified/Illegal Products
Rapid Alert
| DRAP Alert No | No I/S/11-24-45 |
| Action Date | 28th November, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public |
| Problem Statement | Directorate of Drugs Control (DDC) Punjab and Secretary PQCB Quetta have informed DRAP that samples of various products have been identified as spurious (falsified). Details of test reports are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label claim) | Lab Test Results |
| 1 | Titan-1000 Injection Reg# 021743 | CeIftriaxone as Ceftriaxone Sodium 1000 mg/vial | 22044 | Purported to be manufactured by Macter International Limited (as per label claim) F-216, S.I.T.E Karachi | “Spurious” and “Substandard” with regards to Assay and Sterility test, |
| Dyrone Film Coated Tablet Reg# 198069 | Dydrogesterone | DR-121 | Purported to be manufactured by Solvay (as per label claim), Plot # 32, Sector,2 Highway Petaro Road Jamshoro Sindh | Spurious | |
| Solverone 10 mg Film Coated Tablet Reg# 068898 | Dydrogesterone | SVN-001 | Purported to be manufactured by Solvay (Fictitious firm), Plot # 32, Sector,2 Highway Petaro Road Jamshoro Sindh | Spurious | |
| Dydowen 10mg Film Coated Tablet Reg# 101507 | Dydrogesterone | 736 | Purported to be manufactured by Weather Folds Pharmaceuticals, Hattar, Pakistan. Manufactured For: Wenovo Pharmaceuticals Taxila | Spurious | |
| DYDRO-FEM 10 mg Film CoatedTablet Reg# 555199 | Dydrogesterone | DFD10/008 DFD10/009 | Purported to be manufactured by Torrent Pharmaceutical, (as per label claim) G-19, Hawkesbay Road SITE, Karachi. | Spurious | |
| M.CEF 30 mL Powder For Oral Suspension Reg# 0432189 | Cefixime as Trihydrate 100 mg/5mL | D00018 | Purported to be manufactured by Dalton Laboratories PVT LTD. (as per label claim) Plot # G-149, Phase L-II Super Highway Road, S.I.T.E. LI Karachi | Spurious | |
| Iodex Ointment Reg# 000394 | Iodine + Methylsalicylate | HIAAC | Purported to be manufactured by GSK Pakistan Karachi | Counterfeit (Falsified) |
| Risk Statement: | The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems. |
| Action Initiated | The field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the 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 this product. Further information on reporting problems to DRAP is available on this link. 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 Consumer | 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 these 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: Recall of Substandard Flagynase Suspension (Reg. No. 087528) Batch No. 0362 Manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar
Recall Alert
| DRAP Alert No | No I/S/11-24-49 |
| Action Date | 20th November, 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | The Federal Inspector of Drugs, Peshawar collected the samples of Flagynase Suspension and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 0362 of the said product, manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar, as a Substandard product. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Flagynase suspension Reg. No. 087528 | Metronidazole (200mg/5ml) | Batch no. 0362 Mfg date: 10/23 Expiry date: 10/25 | M/s. Aries Pharmaceuticals (Pvt.) Ltd., 1-W, Industrial Estate, Hayatabad, Peshawar. |
| Risk Statement: | Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or suspected. Use of substandard products may lead to suboptimal to no-therapeutic effects and may contribute to drug resistance, and can also intensify/exacerbate the existing bacterial infection. |
| Action Initiated | -The regulatory field force of DRAP and Provincial Drug Control departments have 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 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. |