Recall Alerts – Drug Regulatory Authority of Pakistan

Recall Alert – Orange Auto disable Syringes 5mL (Batch # S5102402), DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

Ahsan Hafiz Recall Alerts September 30, 2025September 30, 2025Recall

Recall Alert

MEDICAL DEVICE DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	N^oI/S/09-25-82
Action Date	30 September, 2025.
Target Audience	– National Regulatory Field Force of DRAP and Provincial Drug Control Departments. – Healthcare Professionals – Physicians, Pharmacists, and Nurses. – General Public
Problem / Issue	Central Drugs Laboratory (CDL) Karachi, has declared the sample of below mentioned Medical Device as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Orange Auto disable Syringes 5ml (MDMR # 000078)	S5102402	M/s Silver Surgical Complex (Pvt) Ltd, C-40, S.I.T.E II, Super Highway Industrial Area Scheem 33, Karachi. (ELM # 0007)	Sample has been declared of ‘substandard’ quality on the basis of results for Auto disable feature.

Risk Statement:	This defect poses a high risk of reuse of syringes, which may result in cross-contamination and transmission of bloodborne infections such as HIV, hepatitis B, and hepatitis C. Because the defect is not visually detectable before use, healthcare professionals and patients remain unaware of the risk. Given the widespread use of such syringes in general healthcare settings, including immunization programs and vulnerable populations, the risk is categorized as HIGH, and immediate market withdrawal and user alert are necessary to protect public health.
Action Initiated	– The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches 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 – FALSIFIED / SPURIOUS DRUG PRODUCT IN THE MARKET.

Ahsan Hafiz Recall Alerts September 26, 2025September 26, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	N^o I/S/09-25-81
Action Date	26th September, 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) have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’* as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Саpsule Eskem 40 MG Each Capsule Contains: Enetric Coated Pellets of Esomeprazole Magnesium Tri-hydrate Equivalent to Esomeprazole ……. 40 Mg (Reg.# 044310)	Not mentioned	Purported to be manufactured by M/s High-Q Pharmaceuticals, Plot No. 224 & 225/1, Sector 23, Korangi Industrial Area, Karachi.	‘Substandard’ with respect to physical characteristics and “Misbranded” as defined under clause (i) of sub-section (s) of section 3 of The Drugs Act, 1976 and “Spurious” as defined under clause (i) & iii of subsection (zb) of section 3 of The Drugs Act, 1976. Details: Product label on outer carton does not bear batch number and immediate blister have illegible embossed marking. Moreover, as per the manufacturer’s method, the product is described as amethyst-colored capsules with the cap imprinted ‘High Q’ in black and the body imprinted Eskem 40, However, no such printing was observed on the actual capsules. Esomeprazole is not identified. Omeprazole is identified.

Risk Statement	Critical non-compliances include absence of batch number on the outer carton, illegible embossed markings on immediate blister packs, and deviation from the manufacturer’s approved description of capsule appearance (color and printing). Analytical testing confirmed that Esomeprazole was not identified and instead Omeprazole was detected, representing potential therapeutic failure and risk of inappropriate treatment. The presence of a spurious and misbranded product in the supply chain poses a serious threat to patient safety due to lack of assured identity, quality, and efficacy and requires immediate regulatory and field action to prevent its distribution and use.
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 AMLOshine (all strengths & batches) – Sunshine Pharmaceuticals

Ahsan Hafiz Recall Alerts September 26, 2025September 26, 2025Recall

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Immediate Withdrawal of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419)

manufactured by M/s Sunshine Pharmaceuticals

DRAP Alert No	N^oII/S/09-25-80
Action Date	26 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	In continuation to DRAP Alert No. N^oII/S/05-25-45 dated 2^nd June 2025, wherein three batches (7840, 7623, 7361) of Tablet AMLOshine 5mg [contains Amlodipine (as Beysalte) 5mg] bearing Reg. # 62420, and manufactured by M/s Sunshine Pharmaceuticals. Emanabad, G.T. Road, Gujranwala (DML # 000662) declared ‘substandard’ by Provincial Drug Testing Laboratory on the basis of impurities testing. The panel of inspectors of DRAP accordingly conducted inspection at manufacturing unit of M/s. Sunshine Pharmaceuticals, Khan Payara, Near Saim Nala, Emanabad, Gujranwala, revealed multiple critical non-compliances with Good Manufacturing Practices (GMP). These included the absence of vendor qualification, failure to perform impurities testing and analytical method validation, unjustified use of API overages, lack of process validation, failure to investigate assay deviations observed in stability data, and the non-availability of impurity reference standards. The panel advised firm to initiate an immediate recall of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419). Registration of Tablet AMLOshine 5 mg (Reg. #062420) and Tablet AMLOshine 10 mg (Reg. # 062419) are under suspension proceedings.

Risk Statement:	The presence of impurities, lack of validated testing, and failure to investigate assay deviations in AMLOshine Tablets may compromise product quality, leading to reduced therapeutic efficacy and potential treatment failure in patients requiring amlodipine for hypertension and cardiovascular conditions. Such deficiencies may also expose patients to unpredictable adverse effects, particularly among the elderly, long-term users, and those with comorbidities. In view of the nature of defect and potential health risks, the issue is classified as a Class II Recall, as the defect may cause illness or treatment failure but is not considered immediately life-threatening.
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 – DRUG PRODUCTS (CLASS – I).

Ahsan Hafiz Recall Alerts September 25, 2025September 25, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/09-25-79
Action Date	25 September, 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 samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000	LG-001	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	“Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
2.	Satamin Injection Each ampoule contains: (Mecobalamin J.P) 500ug	MC24-030	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734).	‘Adulterated’ as per Section_3 (a) (v) of The Drugs Act 1976.

Risk Statement:	The defects identified in the sampled injections pose serious risks to patient safety and therapeutic effectiveness. Injection Lignozin-A 2 mL (Batch LG-001) manufactured by M/s Trigon Pharmaceuticals (Pvt.) Ltd. has been declared Misbranded under Section 3(s)(iv) of the Drugs Act, 1976, and Substandard on the basis of physical description (visible particles), pH, and assay of adrenaline, raising concerns of compromised sterility, safety, and efficacy. Similarly, Satamin Injection (Batch MC24-030) manufactured by M/s Saturn Pharmaceuticals (Pvt.) Ltd. has been declared Adulterated under Section 3(a)(v) of the Drugs Act, 1976, which represents a severe violation of product quality and purity standards. The circulation and use of these defective products may lead to therapeutic failure, unpredictable adverse reactions, and potential harm to patients, warranting urgent regulatory and recall action.
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 – TABLET ASCARD-75 (Batch # AR046L)

Ahsan Hafiz Recall Alerts September 25, 2025September 25, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	N^oII/S/09-25-78
Action Date	23 September, 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 samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Tablet Ascard-75 Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mg	AR046L	M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)	‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).

Risk Statement:	The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible adverse health consequences.
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 – Class II (Tablet Ascard-75) Batch # AR021L

Ahsan Hafiz Recall Alerts September 23, 2025September 25, 2025Recall

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PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	N^oII/S/09-25-77
Action Date	23 September, 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 samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Tablet Ascard-75 Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mg	AR021L	M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)	‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).

Risk Statement:	The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible adverse health consequences.
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 – Class I – Substandard drug Products

Ahsan Hafiz Recall Alerts September 23, 2025September 23, 2025Recall

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PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	N^oI/S/09-25-76
Action Date	23 September, 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 samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000	LG-001	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	The Sample is declared as “Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
2.	Aqua-P Injection Sterile water for injection 5ml	P-679	M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)	‘Sub-standard’ on the basis of “Visible particulate matter” as per USP.
3.	Neocobal Injection 0.5 mg Each ml contains: Mecobalamin.0.5 mg	S-2705	M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)	‘Substandard’ with regards to Assay and ‘Adulterated’ as per Section 3 (a) (v) of The Drugs Act 1976.
4.	Kanadex-N Cream Each gram contains: 1 mg of dexamethasone-21 phosphate in the form of disodium salt U.S.P. 3500 i.u. of Neomycin in the form of Sulphate U.S.P.)	F7-27	M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)	‘Substandard’ with regards to Assay of Dexamethasone Phosphate and Adulterated as per Section 3 (a) (v) of The Drugs Act 1976.
5.	Remedy Injection 500 mcg Each 1ml ampoule contains: 500mcg of Mecobalamin	R-2419	M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)	‘Adulterated’ as per Section 3 (a) (v) of The Drugs Act 1976.

Risk Statement:	The presence of visible particles, failed assays, incorrect active ingredient levels, and adulteration with undeclared or unsafe components renders these medicines unsafe, ineffective, and potentially harmful to patients. Their use may result in treatment failure, unpredictable adverse effects, and serious safety risks including allergic reactions, infections, or toxicity.
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 – PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

Ahsan Hafiz Recall Alerts September 19, 2025September 19, 2025Recall

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PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	N^oI/S/09-25-75
Action Date	19th September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratory Faisalabad has informed the Drug Regulatory Authority of Pakistan 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.	Wisdom powder for injection (Ceftriaxone 500mg)	WSM-027	Trigon Pharmaceuticals (Pvt.) Ltd., Thokar-Raiwind road, Lahore.	Substandard on the basis of failure of sterility test.

Risk Statement:	Use of the affected batches of Ceftriaxone Injection may pose a significant risk to patient safety. As this product is administered parenterally, compromised quality (such as sterility failure) can result in serious adverse health consequences. Potential risks include treatment failure, severe infection, sepsis, or life-threatening hypersensitivity reactions. Vulnerable populations, including neonates, children, and immunocompromised patients, are at particular risk of harm. Therefore, continued distribution or use of the defective product may lead to serious, sometimes fatal, health outcomes.
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 FALSIFIED / SPURIOUS PRODUCTS

Ahsan Hafiz Recall Alerts September 19, 2025September 19, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	N^o I/S/09-25-74
Action Date	19th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Provincial Drug Testing Laboratories have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’*. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Efaston tablet (Dydrogesterone 10mg)	41160	Purported to be manufactured by Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., Lahore.	Spurious (Does not contain active ingredient)
2.	Paracare 60ml suspension (Paracetamol 120mg/5ml)	PE-042	Purported to be manufactured by Wellcare Pharmaceuticals, Sargodha.	Spurious (Does not contain active ingredient)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious, as the laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
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.

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts September 18, 2025September 18, 2025Recall

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/09-25-73
Action Date	18 September, 2025.
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue	Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned Veterinary products have been declared as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Inj. Rasomycin-5 50ml Oxytetracycline HCl – 50 mg /ml	VM800	M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130)	The Drug Testing Laboratory, Bahawalpur has declared the product ‘misbranded’ under Section 3(s)(iv) of the Drugs Act, 1976, and ‘substandard’ due to failure in the Bacterial Endotoxin Test.
2.	Inj. Duralin -50 Oxytetracycline (as HCl) -50mg/ml	5807	M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur. (DML # 000747)	The Drug Testing Laboratory, Multan has declared the product ‘misbranded’ under Section 3(s)(iv) of the Drugs Act, 1976, and ‘substandard’ due to failure in the Sterility Test.

Risk Statement:	These quality defects directly compromise animal safety, therapeutic effectiveness, and indirectly pose risks to public health through the livestock production chain. Therefore, the products are classified as high-risk veterinary medicines requiring immediate regulatory attention.
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.

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