Recall Alerts – Drug Regulatory Authority of Pakistan

05. Recall Alert (Class-I) – Teczone Forte – Batch # 02 – Powder for Injection

Salateen Philip Recall Alerts February 25, 2026February 25, 2026Recall

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DRUG PRODUCT DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	N^oI/S/02-26-05
Action Date	25 February, 2026.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drug Laboratory (CDL) Karachi informed that the samples of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Teczone Forte Powder for Injection Each vial contains: Cefoperazone (as Sodium) ……1gm. Sulbactum …………..1gm. (Reg # 045516)	02	M/s SPL Pharmaceuticals (Pvt) Ltd. Plot No.4 Phase-III Industrial Estate Hattar. (DML # 000605)	The sample has been declared “substandard” on the basis of pH test of reconstituted powder for injection.

Risk Statement:	An abnormal pH may compromise drug stability, efficacy, and patient safety, potentially leading to reduced therapeutic effect, injection site irritation, phlebitis, or systemic adverse reactions. Hospitalized patients receiving intravenous antibiotic therapy, particularly those with severe infections (e.g., sepsis, pneumonia, intra-abdominal infections), immunocompromised individuals, elderly patients, and critically ill patients in ICU settings, as this product is administered parenterally in institutional healthcare facilities.
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.

04. Rapid Alert – “Zetol” Unregistered Antiseptic product

Salateen Philip Recall Alerts February 18, 2026February 18, 2026RapidAlert

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	Unregistered Antiseptic Product “Zetol (Chloroxylenol) Germ Protection Liquid”

DRAP Alert No	N^o I/S/02-26-04
Action Date	18 February, 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, Punjab informed that samples of the below-mentioned products have been found unregistered and declared Substandard and Misbranded under the Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.

Following product is being marketed and sold in Pakistan without prior registration/enlistment with the Drug Regulatory Authority of Pakistan (DRAP)

Product Name	Manufacturer	Label Claim
Zetol Contains: Chloroxylenol Pack Size: 100 ml, 1 Liter Germ Protection Liquid / Antiseptic Liquid	UNCUS BROTHERS Address: 23 KM Multan Road, Lahore	Effective Protection against Germs that cause Infection”

Risk Statement	Use of the unregistered antiseptic product “Zetol (Chloroxylenol) Germ Protection Liquid” may pose a potential risk to public health, as it has not been evaluated or approved by DRAP for its quality, safety, and efficacy. The product contains an active antiseptic substance (Chloroxylenol) and is being marketed with infection-prevention claims without regulatory authorization. Furthermore, its presentation closely resembles an already registered antiseptic brand (Dettol), which may mislead consumers and increase the risk of inappropriate use of an unregulated product. Therefore, continued distribution and use of this product may result in: exposure to substandard or contaminated formulations misleading therapeutic claims consumer deception and confusion potential adverse skin reactions or ineffective infection control.
Action Initiated	· Provincial Drug Control Authorities and DRAP Field Forces have been directed to initiate immediate enforcement action, including market surveillance, seizure, and recall of the affected batch. · Further regulatory action is being taken in accordance with applicable laws.
Advice for Healthcare Professionals	Healthcare professionals, pharmacists, and healthcare institutions are advised to: · Not recommend, prescribe, dispense, or use the unregistered antiseptic product “Zetol (Chloroxylenol) Germ Protection Liquid” in any clinical or household setting. · Ensure that only DRAP registered/enlisted antiseptic and disinfectant products are procured and supplied to patients and the general public. · Be vigilant for any adverse skin reactions, irritation, or lack of expected antiseptic effect associated with the use of this product and report such events through the Pharmacovigilance/Vigilance system. 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 are advised to: · Stop using the unregistered antiseptic product “Zetol (Chloroxylenol) Germ Protection Liquid” immediately. · Do not purchase or rely on this product for infection prevention, as it has not been evaluated or approved by DRAP for quality, safety, or effectiveness. · Be cautious of products that closely resemble well-known registered brands (such as Dettol), as such resemblance may be misleading. · If you have experienced any skin irritation, allergic reaction, or other adverse effects after using this product, consult a healthcare professional and report the event to the relevant health authorities. · Purchase antiseptic and disinfectant products only from reputable sources and ensure they are registered/enlisted with DRAP.

03. Recall Alert (Class-I) – Veterinary Drug Products reports from DTLs Punjab.

Salateen Philip Recall Alerts February 12, 2026February 12, 2026Recall

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/02-26-03
Action Date	12 February, 2026.
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue	Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as *‘Substandard’*.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Injection. I-PENRIT-5 Each vial contains Procaine Penicillin…..1500000 iu, Benzyl Penicillin……500000 iu, Streptomycin Sulphate….5 gm (Reg # 079517)	AM-164	M/s International Pharma Labs. Raiwind Road Bhobtian Chowk Defence Road 1-Km Toward Kahna, Lahore. (DML # 000582)	The sample is Sub-Standard with regards to Sterility Test .
2	Duralin 50 Injection OXYTETRACYCLINE ……..50MG/ml (Reg # 078206)	5782	M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur. (DML # 000747)	The sample is Misbranded with regards to labelling as defined under Section 3(s)(iv) of the Drugs Act,1976 and Substandard on the basis of Sterility Test.
3.	Ivotek Injection Ivermectin 10 mg/ml (Reg # 016284)	VM583	M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130)	The sample is Sub-Standard with regards to Related substance.
4.	Oxytovetz injection 50 ml Oxytocin 10IU/ML	25129681	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	The sample is Sub-Standard with regards to Sterility Test & Assay test .

Risk Statement:	These veterinary medicines present a moderate to high risk, primarily affecting livestock health and indirectly the general public. Substandard sterile injectable antibiotics (Penicillin/Streptomycin and Oxytetracycline) failing sterility tests may cause severe infections, abscess formation, treatment failure, and animal deaths, particularly in dairy cattle, poultry, and farm animals. Misbranding and quality defects can also lead to incorrect dosing and misuse by farmers and veterinarians. Substandard ivermectin with related substance issues may reduce effectiveness against parasites and increase the risk of drug resistance. Oxytocin injection failing sterility and assay tests is of serious concern as it is used during animal delivery and milk production, potentially causing reproductive complications and economic loss. The most likely to be affected are farmers, veterinarians, dairy producers, and consumers, due to possible consequences such as reduced food safety, antibiotic residues in milk/meat, and public exposure through the food supply chain.
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 and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.

02. Recall Alert (Class-II) – Drug Products tested by DTL Punjab

Salateen Philip Recall Alerts February 12, 2026February 12, 2026Recall

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	DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.

DRAP Alert No	N^oII/S/02-26-02
Action Date	12 Febraury, 2025.
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.	TABLET ASCARD-75 Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin) 75mg (Reg # 016600)	AR065L, AR047L	M/s Atco Laboratories Limited. B-18 S.I.T.E Karachi. (DML # 000188)	The sample has been declared “Substandard” with respect to test performed for “Related Substances”
2.	Tablet Daisy 10 mg Each film coated tablet contains: Cetirizine dihydrochloride USP 10mg (Reg # 032865)	24F213	M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)	The sample has been declared “Sub-Standard” with regards to Impurities Tests.
3.	Tablet Sapizine 10 mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 054261)	13098	M/s Sapient Pharma. 123-S Industrial Area Kot Lakhpat Lahore. (DML # 000207)	The sample has been declared “Sub-Standard” with regards to Impurities Tests.
4.	Tablet Rozen 10mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 040161)	5F006	M/s Rasco Pharma (Pvt) Ltd. 5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530)	The sample has been declared “Sub-Standard” with regards to Impurities Tests.
5.	Cream Kanadex-N Each gram contains: Dexamethasone-21 phosphate in the form of disodium salt 1mg Neomycin in the form of sulphate 3500I.U (Reg # 012475)	17-54, C8-26	M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)	The sample is declared “Substandard” on the basis of the assay of Dexamethasone Phosphate (as disodium salt), and “Adulterated” on the basis of the identification and quantification of Dexamethasone (base) in HPLC analysis (which is an undeclared active pharmaceutical ingredient not stated on the product label.

Risk Statement:	These products present a moderate to high public health risk, mainly affecting the general outpatient population, especially cardiac patients, allergy sufferers, children, and chronic medicine users. Substandard aspirin (Ascard-75) with excessive related substances may increase the risk of gastrointestinal irritation, bleeding, or reduced cardiovascular protection in patients using it for long-term prevention of heart attack or stroke. Multiple cetirizine brands failing impurity tests could expose the public—particularly children and individuals with liver or kidney compromise to unexpected toxic effects or reduced safety margins, even though the medicine is generally used for minor allergic conditions. The highest concern is Kanadex-N cream, where adulteration with an undeclared corticosteroid base can lead to misuse, skin thinning, hormonal suppression, masking of infections, and serious harm in infants or prolonged users, making dermatology patients and self-medicating consumers the most likely to be affected.
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.

01. Recall Alert (Class-I) – Drug Products tested by DTL Punjab.

Salateen Philip Recall Alerts February 12, 2026February 12, 2026Recall

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	DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.

DRAP Alert No	N^oI/S/02-26-01
Action Date	12 Febraury, 2025.
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.	PSOL 2 ml . Sterile water for injection (Reg. # 098431)	AK144	M/s Pharmasol (Pvt) Ltd. Plot 549, Sunder Industrial estate, Lahore. (DML # 000872)	The sample has been declared “Substandard” with respect to Endotoxin test performed.
2.	Nafen Ophthalmic Suspension Each ml conatins: Nepafenac 1 mg (Reg # 075907)	4231	M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi. (DML # 000030)	The sample has been declared “Substandard” on the basis of Sterility test.
3.	Metrorise Infusion Metronidazole….500mg/100ml (Reg # 040412-D)	LV-2506	M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)	The sample has been declared “Substandard” on the basis of Bacterial Endotoxin Test & Visible particles.
4.	Metroin Infusion IV Metronidazole….500mg/100ml (Reg # 071279)	MT25-331	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734)	The sample has been declared “Substandard” on the basis of Bacterial Endotoxin Test.
5.	Satamin Injection Mecobalamin………500mcg (Reg # 071284)	MC24-022, MC24-023, MC24-026, MC25-001	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734)	The sample has been declared Substandard on the basis of Assay test and Adulterated on the Quantification of Cyanocobalamin.

Risk Statement:	These findings indicate a high public health risk, primarily affecting hospitalized patients and vulnerable groups. The most likely to be harmed are neonates, children, elderly patients, immunocompromised individuals, post-surgical patients, and those receiving IV therapy or ophthalmic treatment. Substandard sterile water and infusions failing endotoxin/sterility tests can lead to serious bloodstream infections, septic shock, pyrogenic reactions, and even fatalities, especially in intensive care settings. The presence of visible particles further increases the risk of embolic or inflammatory complications. The adulteration and incorrect potency in Satamin injection may result in therapeutic failure, delayed neurological recovery, or unexpected adverse effects, undermining patient safety. Overall, these products pose the greatest risk in clinical and emergency care environments, where sterile injectable medicines are critical.
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.

136. Rapid Alert – Spurious Tablet EFASTON – Batch # 51062

Salateen Philip Recall Alerts January 23, 2026January 23, 2026RapidAlert

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SPURIOUS (TABLET EFASTON 10mg) – Batch # 51062

DRAP Alert No	N^o I/S/01-26-136
Action Date	23 January , 2026
Target Audience	· Regulatory Field Force of DRAP and Provincial Drug Control departments. · Healthcare Professionals (Gynecologists, Obstetricians, Pharmacists, Drug Distributors, Hospitals, Clinics,) · Consumers (General Public)
Problem Statement	The Drug Regulatory Authority of Pakistan has been informed through an official test/analysis report issued by the Drug Testing Laboratory, Government of the Punjab, that a sample of Efaston® (Dydrogesterone) 10 mg film-coated tablets (Reg. # 064835), Batch No. 51062, manufactured by Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., Lahore (DML # 000064), has been declared SPURIOUS under Section 3(zb)(i) of the Drugs Act, 1976. Laboratory analysis confirmed that the declared active ingredient Dydrogesterone was not identified, and assay results showed 0.0 mg per tablet, despite a labeled strength of 10 mg.

The product identification details are as under: –

Risk Statement	Efaston® (Dydrogesterone) is commonly prescribed for gynecological and obstetric indications. Use of a spurious product containing no active ingredient may result in therapeutic failure, leading to serious clinical consequences, including unmanaged hormonal conditions, pregnancy-related complications, and risk to maternal health.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product. · The product has been declared SPURIOUS under the Drugs Act, 1976. · Provincial Drug Control Authorities and DRAP Field Forces have been directed to initiate immediate enforcement action, including market surveillance, seizure, and recall of the affected batch. · Further regulatory action is being taken in accordance with applicable laws.
Advice for Healthcare Professionals	Healthcare professionals are advised to immediately stop prescribing, dispensing, or using Efaston® (Dydrogesterone) 10 mg, Batch No. 51062. All available stock should be verified to ensure procurement from authorized sources only, and any suspected presence of the affected batch in the supply chain must be promptly reported to DRAP or the concerned Provincial Drug Control Authorities. In addition, patients who may have received the said product should be appropriately identified, monitored, and managed clinically in accordance with standard medical practice. 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 are advised not to use Efaston® (Dydrogesterone) 10 mg tablets of Batch No. 51062. If this product is currently being used, patients should immediately consult their healthcare provider for appropriate medical advice and further management. Medicines should only be purchased from licensed pharmacies, and any suspected or doubtful products should be promptly reported to the concerned drug inspectors or to DRAP.

134. Recall Alert (Class-II) – CDL declared substandard – Henafim Paediatric Suspension

Salateen Philip Recall Alerts January 21, 2026January 21, 2026Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

DRAP Alert No	N^oII/S/01-26-134
Action Date	14 January, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drug Laboratory (CDL) Karachi informed that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch	Manufacturers	Remarks
1.	Henafim Paediatric Suspension Each 5ml contains: Paracetamol …. 120mg Chlorphineramine Maleate …. 1mg (Reg. # 078545)	558	M/s Wisdom Pharmaceutical Industry. (DML # 000780) 78-A Industrial Estate Hayatabad Peshawar.	The samples have been declared “Sub-Standard” on the basis of assay test of Paracetamol (71%) & Chlorpheniramine Maleate (81%).

Risk Statement:	The use of Henafim Paediatric Suspension, Batch No. 558, poses a potential risk to public health, particularly affecting infants and children, who are the primary users of this product for the management of fever, pain, and allergic symptoms. The product has been declared sub-standard due to low assay results of Paracetamol (71%) and Chlorpheniramine Maleate (81%), which may lead to inadequate therapeutic response, resulting in poor fever control, persistent discomfort, and unresolved allergic symptoms. This may prompt caregivers to administer repeated or higher doses, increasing the risk of medication misuse. Although not adulterated, the reduced potency of this paediatric formulation may compromise effective treatment in a vulnerable population, warranting regulatory attention and appropriate risk management.
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.

135. Rapid Alert – Unregistered OMNIVISC 2% (Substandard & Misbranded)

Salateen Philip Recall Alerts January 21, 2026January 21, 2026RapidAlert

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Unregistered, Substandard /Misbranded – OMNIVISC 2%

DRAP Alert No	N^o I/S/01-26-135
Action Date	21 January , 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, Punjab informed that samples of the below-mentioned products have been found unregistered and declared Substandard and Misbranded under the Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.

The product identification details are as under: –

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mL	OMV190171	*(purported to be manufactured by)* M/s Omni Lens Pvt. Ltd., Plot No. 17, Ambota, Sector-5, Parwanoo Distt. Solan (H.P.), India	The sample has been declared Substandard on the basis of failed sterility test (Non-sterile) and Misbranded due to labeling discrepancies including mismatch of batch number on labels, absence of Pakistan Drug Registration Number, absence of Urdu instructions, and non-mentioning of maximum retail price.
2	Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mL	OMV191171	*(purported to be manufactured by)* M/s Omni Lens Pvt. Ltd., Plot No. 17, Ambota, Sector-5, Parwanoo Distt. Solan (H.P.), India	The sample has been declared Substandard on the basis of failed sterility test (Non-sterile) and Misbranded due to absence of Pakistan Drug Registration Number, incomplete labeling particulars including Urdu instructions and maximum retail price, in violation of Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.

Risk Statement	The use of Omnivisc 2% (HPMC) Ophthalmic Solution, Batches OMV190171 and OMV191171, poses a serious and vision-threatening public health risk due to failure of sterility testing, rendering the product non-sterile, and due to misbranding. Ophthalmic preparations are required to be sterile, and the use of a non-sterile eye product may lead to severe ocular infections, including conjunctivitis, keratitis, endophthalmitis, corneal ulceration, and potential irreversible loss of vision or blindness. The absence of proper labeling information, including DRAP’s Drug Registration Number and usage instructions in Urdu, increases the risk of misuse, inappropriate dosing, prolonged use, and delayed medical intervention. Patients undergoing eye surgery, those with corneal injuries, contact lens users, and immunocompromised individuals are at particularly high risk. Continued circulation and use of these batches may therefore result in serious ocular morbidity, warranting immediate regulatory action and strict removal from the supply chain.
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	Healthcare professionals, including ophthalmologists, general practitioners, pharmacists, and nursing staff, are advised to exercise heightened vigilance regarding the use and supply of Omnivisc 2% (HPMC) Ophthalmic Solution, Batch Nos. OMV190171 and OMV191171. They should immediately discontinue prescribing, dispensing, or administering these batches and ensure their removal from institutional and retail inventories. Patients who may have been exposed to these products should be clinically evaluated for signs of ocular infection or adverse reactions, particularly post-operative eye patients and contact lens users. 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 are strongly advised to immediately stop using Omnivisc 2% (HPMC) Ophthalmic Solution, particularly Batch Nos. OMV190171 and OMV191171, and to check product labels and batch numbers carefully. Any remaining stock should be isolated and returned to the point of purchase and not used further. Individuals who have already used these eye drops and experience symptoms such as eye redness, pain, discharge, blurred vision, sensitivity to light, or worsening of eye condition should seek immediate medical attention from an ophthalmologist. Patients who have recently undergone eye surgery, suffered eye trauma, or have underlying eye infections are at higher risk and should be especially vigilant. Consumers are also encouraged to report the product and any suspected adverse effects to the relevant health authority to help prevent further harm and protect public health.

133. Recall Alert (Class-I) – Tablet BP-NORM (Substandard & Adulterated)

Salateen Philip Recall Alerts January 21, 2026January 21, 2026Recall

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DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.

DRAP Alert No	N^oI/S/01-26-133
Action Date	21 January, 2025.
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.	Tablet. BP-NORM Atenolol … 50mg (Reg. # 071447)	5968P485	M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)	The sample has been declared Substandard on the basis of failed assay of Atenolol, &Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (confirmed presence of an undeclared active ingredient i.e. Ciprofloxacin HCl)

Risk Statement:	The use of BP-NORM (Atenolol 50 mg), Batch No. 5968P485, presents a serious risk to public health, particularly for patients with cardiovascular diseases such as hypertension, ischemic heart disease, arrhythmias, and the elderly who depend on consistent atenolol therapy. The product is substandard due to failed assay of atenolol, which may result in loss of therapeutic control, and is adulterated by the confirmed presence of an undeclared active ingredient, Ciprofloxacin HCl. This may expose patients to unintended antibiotic intake, leading to adverse reactions, drug interactions, and development of antimicrobial resistance, especially in vulnerable patients. Continued use of this batch may therefore cause significant harm, warranting immediate risk mitigation.
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.

132. Recall Alert – Veterinary Products – Substandard by DTLs Punjab.

Salateen Philip Recall Alerts January 14, 2026January 14, 2026Recall

Recall Alert

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/01-26-132
Action Date	14 January, 2026.
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue	Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as *‘Substandard’*.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Injection, Actimec 10ml Ivermectin: 10 mg/ml (Reg # 034595)	AM-164	M/s Selmore Pharmaceuticals (Pvt) Ltd. 36 Km Off. Multan Road Lahore. (DML # 000507)	The sample is declared as “Sub-Standard” on the basis of Assay Test & Test for Related Substances.
2	MAC ROLD 1% 50ml Ivermectin: 10 mg/ml (Reg # 106810)	YI-146	M/s Haarlods Pharmaceuticals (Pvt) Ltd. Plot No.60-64/C, Small Industrial Estate, Bhimber, AJK. (DML # 000921)	The sample is declared as “Sub-Standard” on the basis of Assay Test, sterility test & Related Substances, while misbranded as per section 3(s)(vi) of the Drugs Act,1976. (Product does not contain Finished Drug Product Specifications)

Risk Statement:	The above veterinary ivermectin injectable products have been declared Sub-Standard due to failures in Assay, Related Substances, and Sterility tests, with one product also found misbranded for not meeting Finished Drug Product specifications. Use of such compromised injections may result in treatment failure, toxicity, infections, or adverse reactions in animals. The public most likely to be affected includes livestock farmers, dairy and meat producers, veterinarians, and animal handlers, as defective treatment can lead to animal illness, reduced productivity, economic losses, and potential downstream risks to milk and meat 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 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 and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.

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