Safety Info
95. Recall Alert – Veterinary Drug Product declared Substandard.
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/10-25-95 |
| Action Date | 16th October, 2025. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | Drug Testing Laboratory from Province informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned Veterinary product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Details | Batch # | Manufacturer details | Remarks |
| 1. | Oxytocin Injection 50ml Oxytocin Synthetic 10-IU/mL (Reg. # 019928) | V8-5 | M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126) | The sample is declared “sub-standard” on the basis of Sterility testing. |
| Risk Statement: | The use of Oxytocin Injection 50 ml (Batch No. V8-5) declared sub-standard on the basis of sterility testing, poses a significant risk to livestock health and animal productivity. As Oxytocin is commonly administered to dairy animals such as cows and buffaloes to induce milk let-down and facilitate parturition, use of a non-sterile injection may lead to severe local infections, fever, abscesses, or systemic septicemia in treated animals. This can result in economic losses to farmers and potential contamination of milk supply. All veterinarians, livestock owners, and distributors are therefore advised to immediately discontinue the use and sale of the affected batch and ensure that only quality-assured and sterile veterinary injectable preparations are procured from licensed sources. |
| 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 Veterinarian | This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice. |
| Advice for Farmers and Livestock Owners | Farmers, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses. |
94. Recall Alert (Class-II) – Substandard Drug Products.
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No II/S/10-25-94 |
| Action Date | 16th October, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Kanabax Cream 15gm Each Gram contains: Dexamethasone ………… 1mg Neomycin sulphate ……… 3.5mg | KNX-272 | M/s Baxter Pharmaceuticals. A-1/A Scheme No. 33 Phase-I S.I.T.E. Super Highway Karachi. (DML # 000700) | The sample is declared as “misbranded” with regards Labelling as per Section 3(s)(iv), ‘adulterated’ with regards to Section 3(a)(iv) of the Drugs Act,1976 & ‘substandard’ on the basis of Assay of Dexamethasone Phosphate. |
| 2. | Zysic Tablet 10 mg Each film coated tablet contains: Cetirizine HCI (USP) … 10mg | 727 | M/s Jinnah Pharmaceuticals (Pvt) Ltd. 13-Km Lahore Road Multan. (DML # 000578) | ‘Sub-Standard’ with regards to Impurities Test. |
| Risk Statement: | Use of Kanabax Cream (Batch No. KNX-272), declared misbranded, adulterated, and substandard, may lead to ineffective treatment, worsening of skin infections, or antimicrobial resistance, particularly in children and patients with chronic skin conditions. Similarly, Zysic Tablet 10 mg (Batch No. 727), found substandard due to impurities, may cause reduced efficacy or mild adverse effects in allergic or asthmatic individuals. Consumers are advised to avoid these batches and seek medical advice if already used. |
| 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. |
93. Recall Alert- Syrup Synadin 60ml (Batch # L24K110) -Substandard
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/10-25-93 |
| Action Date | 16th October, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Syrup Synadin 60ml Loratadine: 5mg/5ml | L24K110 | M/s Synchro Pharmaceuticals. 77-Industrial Estate Kot Lakhpat Lahore. (DML # 000575) | The sample is declared as “sub-standard” on the basis of Physical Description Test, Assay Test & it contains the impurity Ethylene Glycol above the permissible limit. |
| Risk Statement: | Use of Synadin Syrup (Batch No. L24K110), declared substandard due to assay failure and presence of ethylene glycol impurity above permissible limits, poses a potential toxic risk, especially for children who are the primary users of antihistamine syrups. Consumers and healthcare providers are advised to immediately stop use of these batches and report any adverse events to DRAP or concerned authorities. |
| 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. |
RAPID ALERT – SPURIOUS / FALSIFIED (TABLET FEMARA 2.5 mg)
Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCT
| DRAP Alert No | No I/S/10-25-92 |
| Action Date | 16th October, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Novartis Pharma (Pakistan) Ltd., Karachi informed DRAP that falsified Femara® 2.5 mg Film Coated Tablet bearing Batch # TELX5 has been identified in the Pakistani market. The reported batch number is not imported, manufactured, or supplied by Novartis Pharma (Pakistan) Ltd., i.e. the genuine registration holder in Pakistan. The packaging falsely uses the Novartis name and branding, but it does not come from the authorized supply chain. |
The product identification details are as under: –
| Risk Statement | In the case of Femara® 2.5 mg Film Coated Tablet (Batch No. TELX5), such falsification may lead to ineffective treatment of hormone-dependent breast cancer, resulting in disease progression or relapse. This poses a serious risk to female cancer patients, particularly post-menopausal women, who depend on this medicine for long-term therapy. This alert applies only to Batch No. TELX5 and does not affect other genuine batches of Femara® available in the market from the authorized registration holder. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product. 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 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. |
RAPID ALERT – SPURIOUS/FALSIFIED (TABLET MYTEKA 10 mg)
Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCT
| DRAP Alert No | No I/S/10-25-91 |
| Action Date | 16th October, 2025 |
| 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 from Punjab informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company which has formally disowned the said product. The details of report are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Manufacturer | Remarks |
| 1. | Tablet Myteka 10 mg Each film coated tablet contains: Montelukast Sodium eq. to Montelukast …. 10 mg | 156428 | Purported to be manufactured by: M/s HILTON PHARMA (PVT) LTD. PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI, | Sample is ‘Spurious’ as described under Section 3(zb)(i) & (ii) of Drugs Act 1976. |
| Risk Statement | Use of Myteka Tablet 10 mg (Batch No. 156428), falsely labeled as manufactured by M/s Hilton Pharma (Pvt.) Ltd., has been declared spurious and substandard, as testing revealed no active ingredient and the product is falsified under Section 3(zb)(i)&(ii) of the Drugs Act, 1976. Such falsified medicine poses a serious risk of treatment failure and adverse outcomes, particularly for asthmatic and allergic patients relying on genuine therapy. Consumers and healthcare professionals are advised to immediately stop using the said batch, verify authenticity, and report any suspected productsto DRAP or the concerned Provincial Drug Control authority. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. 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 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. |
Recall Alert – Tablet Cloferd 50 mg (Batch # 6926) declared Substandard.
Recall Alert
DRUG PRODUCT DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No II/S/10-25-90 |
| Action Date | 15th October, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Provincial Health Department informed the Drug Regulatory Authority of Pakistan 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 Cloferd 50 mg Each film coated tablet contains: Clomiphene Citrate .. 50mg (Reg. # 066676) | 6926 | M/s Medizan Laboratories (Pvt) Ltd. Plot No 313 Industrial Triangle Kahuta Road Islamabad. (DML # 000572) | The Sample is declared as “Sub-Standard” on the basis of Dissolution Test. |
| Risk Statement: | Clomiphene Citrate is indicated for the treatment of female infertility and ovulatory disorders. Use of a substandard product with inadequate dissolution may lead to reduced therapeutic efficacy, resulting in failure of ovulation induction, delayed conception, or treatment frustration in women of reproductive age undergoing fertility management. Timely identification and withdrawal of the affected batch are essential to prevent therapeutic failure and ensure patient safety. |
| 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. |
Recall Alert – Adulterated Tablet Virtec 10 mg (Batch # FK-24-007)
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/10-25-89 |
| Action Date | 15th October, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Provincial Health Department informed the Drug Regulatory Authority of Pakistan 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. | Тablet Virtec Each film coated tablet contains: Cetirizine Dihyrochloride 10 mg (Reg # 021870) | FK-24-007 | M/s Don Valley Pharmaceuticals (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000395) | Sample is “Adulterated” as defined under clause (iv) of sub-section (a) of section 3 of The Drugs Act, 1976 as it contains “Paracetamol” as an ingredient a substance other than the prescribed substance i.e., Cetirizine Hydrochloride. |
| Risk Statement: | The presence of an undeclared pharmacologically active substance poses a serious risk to patient safety, as it may lead to unintended therapeutic effects, drug interactions, or dosing errors, particularly in patients concurrently taking Paracetamol-containing preparations or with hepatic impairment. This adulteration compromises the safety, efficacy, and quality of the product and indicates a critical lapse in manufacturing and quality assurance systems at the firm. |
| 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. |
RAPID ALERT – CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
Rapid Alert
CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
| DRAP Alert No | No I/S/10-25-88 |
| Action Date | 14th October, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan (DRAP) that the following purported drug product has been declared ‘spurious/falsified’ upon analysis and reportedly manufactured by entity not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Manufacturer | Remarks |
| 1. | CОХЕТО 120mL. (SUSPECTED TO CONTAIN VITAMIN E, VITAMIN D AND COPPER SULPHATE) | 005/APN, | ALI’s Pakistan Plot # 10, Street # 01, Al-Ghani Estate, Dullu Khurd Industrial Area, Ferozpur Road, Lahore. | ‘Falsified’ Sample contains suspected ingredients i.e. Vitamin E and does not contain Vitamin D & Copper Sulphate. |
| 2. | Payodine 60ml Each 100ml contains: Povidone-Iodine 10 gm equivalent to 1.0 gm available Iodine (1% w/v) | 2709 | S.A.R LAB Plot # 186, Korangi No. 04, Industrial Area Karachi | Sample declared as ‘Spurious’ |
| Risk Statement | Purported drug product has been confirmed as falsified/spurious, as manufactured by entity neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). This product being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredient, indicating a complete lack of therapeutic value. The circulation and use of such unregulated product pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. 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 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. |
RAPID ALERT – SPURIOUS DETECTED – Injection OXYZON 5% (Veterinary)
Rapid Alert
SPURIOUS DETECTED – Injection OXYZON 5% (Veterinary)
| DRAP Alert No | No I/S/10-25-87 |
| Action Date | 13th October, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Directorate of Drugs Control Punjab informed Drug Regulatory Authority of Pakistan that the sample of below mentioned Veterinary drug product has been declared as ‘Spurious’. |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Injection OXYZON 5% Each ml contains: Oxytetracycline Hcl ……. 50mg | AP/INJ-G/24-18 | M/s. Amazon Pharmaceutical (Pvt) Ltd. Plot No. 10/A & 29/B, Small Industrial Estate, Bhimber, AJK (DML # 000881) | The Sample is declared as “SPURIOUS” as per section 3(zb)(i) of the Drugs Act 1976. |
| Risk Statement | The circulation of such a product in the market poses a serious public health hazard, particularly in rural and peri-urban livestock-dependent populations, where injectable antibiotics are widely used without adequate medical supervision. The unverified origin and uncertain quality of this spurious drug may lead to therapeutic failure, antimicrobial resistance, and potential toxicity in animals, indirectly affecting the food chain and community health. This situation raises grave concerns regarding the integrity of manufacturing and distribution practices, warranting urgent and coordinated regulatory intervention to protect public and veterinary health. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Spurious product. 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 Professionals | Healthcare professionals, veterinarians, and distributors are advised to immediately discontinue the use, prescription, or sale of Injection OXYZON 5% (Batch No. AP/INJ-G/24-18) manufactured by M/s Amazon Pharmaceutical (Pvt) Ltd., Bhimber (DML #000881), as the product has been declared “Spurious” and its safety, efficacy, and quality cannot be assured. They should verify stock authenticity through label and batch details before administration or dispensing, report any adverse reactions or therapeutic failures to DRAP’s Med Vigilance Cell or the concerned Provincial Quality Control Office, and ensure the use of only registered, traceable products obtained through authorized supply chains in compliance with the Drugs Act, 1976 and DRAP Act, 2012. |
| Advice for Consumers | Animal owners are advised not to use Injection OXYZON 5% (Batch No. AP/INJ-G/24-18) manufactured by M/s Amazon Pharmaceutical (Pvt) Ltd., Bhimber (DML #000881), as it has been declared “Spurious” and may pose serious health risks. They should stop using any remaining stock immediately and report the product to the nearest Drug Inspector, Provincial Health Department, or DRAP Field Office. Always purchase medicines and veterinary products only from licensed pharmacies or authorized distributors, ensure the product has a valid registration number, and avoid medicines of unknown or unverifiable origin to protect health and safety. |