Recall Alert – Drug Products declared substandard

Ahsan Hafiz Recall Alerts October 9, 2025October 9, 2025Recall

Recall Alert

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/10-25-86
Action Date	09th October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Provincial Health Departments 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 Rolekast 10mg Each film coated tablet contains: Montelukast (as Sodium)…10 mg	1397	M/s Roryan Pharmaceutical industries (Pvt) Ltd. 85-B Hayatabad Industrial Estate Peshawar. (DML # 000566)	The sample is declared as “Sub-Standard” on the basis of Dissolution Test and impurities test.
2.	AME-CLOP Injection Each 2mL contains: Metoclopramide HCL….10mg	MC-126	M/s Ameer Pharma (Pvt) Ltd. 23-Km Sheikhupura Road, Lahore. (DML # 000604)	sample is ‘Sub-Standard’ on the basis “Particulate contamination: visible particles” as per BP.
3.	Infusion DORCIP Each ml contains: Ciprofloxacin (as Lactate)….2mg	DC-120	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	The Sample is declared as “Sub-Standard” on the basis of Visible Particulates, pH Test, Sterility Test and Bacterial Endotoxin Test (BEТ).

Risk Statement:	Tablet Rolekast 10 mg (Batch 1397), used for asthma and allergic rhinitis in children and adults, has failed dissolution and impurity tests. AME-CLOP Injection (Batch MC-126), used for severe nausea, vomiting and gastrointestinal disorders in patients including pregnant women, surgical and chemotherapy cases, contains visible particles posing risk of embolism and infection and DORCIP Infusion (Batch DC-120), used in serious infections among adults and critically ill patients, failed sterility, endotoxin and pH tests, risking sepsis and life-threatening reactions. Use of these defective medicines can cause ineffective treatment, adverse reactions, and serious safety hazards. Healthcare providers and distributors must immediately stop use and sale, quarantine affected stock, and return it to the supplier, while patients should discontinue these batches and seek medical advice if exposed.
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.

DRAP Alert No	N^o I/S/09-25-85
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	Drug testing Laboratories from Provinces 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:

S#	Product Name	Batch	Manufacturer	Remarks
1.	Cipotic – D® Sterile Eye Drops Each ml contains Ciprofloxacin (as HCl) … 1 mg Dexamethasone ………. 1 mg	F1538	Purported to be manufactured by M/s Barrett Hodgson Pakistan (Pvt) Ltd. F/423 SITE Karachi.	Sample declared *“Spurious”with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976 and ‘substandard’* on the basis of pH & sterility test.
2.	Tablet Danzen DS Each enteric coated tablet contains: Serratiopeptidase ………… 10 mg (20,000 serratiopeptidase units)	3945	Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi.	Sample declared *“Spurious”*with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
3.	Tablet Tebisil 250 mg Each tablet contains: Terbinafine (as HCl) …. 250 mg	517	Purported to be manufactured by M/s Saffron Pharmaceuticals (Pvt) Ltd. 19-Km Sheikhupura Road Faisalabad	Sample declared *“Spurious”* with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
4.	Capsule Cefspan 400 mg Each Capsule contains: Cefixime …………….400 mg	F0580	Purported to be manufactured by M/s Barrett Hodgson Pakistan (Pvt) Ltd.F/423 SITE Karachi.	Sample declared *“Spurious”* with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
5.	Tablet Brexin 20 mg Each tablet contains: Piroxicam B-Cyclodextrine eq. to Piroxicam ………………. 20 mg	1206410	Purported to be manufactured by CHIESI FARMACEUTICI S.p.A.- 26/A, Via Palermo -PARMA-ITALY	Sample declared “Spurious” with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.

Risk Statement	The above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. 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.

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Injection Micrise-2% 50ml Ivermectin: 20 mg/ml	MR-075	M/s Biorise Pharmaceuticals. 19-Km, Lahore Road, Multan. (DML # 000934)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test.
2.	Injection Ivozon 2% 10 ml Ivermectin: 20 mg/ml	AP/INJ-G/25-83	M/s. Amazon Pharmaceutical (Pvt) Ltd. Plot No. 10/A & 29/B, Small Industrial Estate, Bhimber, AJK (DML # 000975)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
3.	Injection IVERMEC 1% 50ml Ivermectin: 10 mg/ml	GI – 25E 140	M/s Grand Pharma (Pvt) Ltd. Plot No. 5-A Street No. N-5 National Industrial Zone Rawat (DML # 000680)	The sample is declared as “Sub-Standard” on the basis of Chromatographic Purity Test.
4.	Injection Selmec 50 ml Ivermectin: 20 mg/ml	SN-116	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 and Test for Related Substances.
5.	Injection Ivomek 2% 10 ml Ivermectin: 20 mg/ml	NI-807	M/s Nawal Pharmaceuticals. Plot No. 11-A Punjab Small Industrial Estate Taxila. (DML # 000735)	The sample is declared as ‘Misbranded’ as per section 3(s)(vi) of the Drugs Act 1976 & 3(g)(i) of the Drugs (Labelling and Packing) Rules 1986, and “Substandard” on the basis of Assay Test and Chromatographic Purity Test.
6.	Injection Ivergen 50ml Ivermectin: 10 mg/ml	594.IV	M/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances
7.	Injection Fosphovetz Each ml contains: Butaphosphan (MS)……100mg Cyanocobalamine (B.P)..50mcg Taurine (USP)……………37.3mg Nicotinamide (B.P) ……….23mg DL-Methionine (B.P) ….18.7mg	24119013	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	The Sample is declared as “Sub-Standard” on the basis of Assay of Cyanocobalamine and Bacterial Endotoxin Test (BET).
8.	Oxyvetz 5% 100ml Injection Each ml contains: Oxytetracycline HCI BP….50mg	25157083	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	Sample is ‘Sub-standard’ with regards to Bacterial Endotoxins Test and Misbranded with regards to Labelling (as per Section 3 (s) (iv) of The Drugs Act 1976).

Risk Statement:	Laboratory testing identified serious quality defects including assay failure, excessive impurities/related substances, misbranding of label information, and failure of bacterial endotoxin and sterility-related tests. These medicines are widely used for livestock and food-producing animals (e.g., cattle, sheep, goats) for parasitic control, metabolic support, and infection treatment. Their use can lead to ineffective therapy, toxic reactions, contamination risk, and unsafe drug residues in milk and meat, posing both animal health and public health hazards. 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.

Drug Regulatory Authority of Pakistan

Recall Alert – Drug Products declared substandard

Recall Alert

Therapeutic Goods (s) Affected: –

RAPID ALERT – FALSIFIED / UNAUTHORIZED MANUFACTURER

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Recall Alert – Veterinary Drug Products (Substandard)

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RAPID ALERT: UNREGISTERED & SUBSTANDARD — LEVITRA 20 mg TABLET (Batch BXNZ2488)

Rapid Alert

Therapeutic Good Affected:-

Guidelines for Referring the Cases for Prosecution under the DRAP Act, 2012 and the Drugs Act, 1976

Minutes of 350th Meeting of the Registration Board

Minutes of M-99 of the Medical Devices Board

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

Recall Alert

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RAPID ALERT – FALSIFIED / SPURIOUS DRUG PRODUCT IN THE MARKET.

Rapid Alert

Therapeutic Good Affected:-

RECALL ALERT -TABLET AMLOshine (all strengths & batches) – Sunshine Pharmaceuticals

Recall Alert

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.

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.