Home > Safety Info > Product Recalls > Recall Alerts > Recall Alert (Class-I) – Drug Products declared substandard by Directorate of Drugs Control Punjab (DDCP)

Recall Alert (Class-I) – Drug Products declared substandard by Directorate of Drugs Control Punjab (DDCP)

Ahsan Hafiz Recall Alerts

Recall Alert

Download

DRAP Alert NoNo I/S/09-25-63
Action Date15 September, 2025.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1STERILE OPHTHALMIC SUSPENSION 5 ML BROMYCIN-D   Each ml contains: TOBRAMYCIN 3MG, DЕХАМЕТHASONE 1MG    6892M/s Innvotek Pharmaceuticals. Plot No.35 Industrial Estate Kahuta Triangle Islamabad. (DML # 000487)Drug Testing Laboratory, Rawalpindi declared the sample as ‘substandard’ quality on the basis of the result of Sterility test.
2.Injection Metrorise   Each 100ml vial contains: Metronidazole USP … 500mg (0.5% w/v)  LV-2504  M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)  Drug Testing Laboratory, Bahawalpur declared the sample as ‘substandard’ quality on the basis of the result of Bacterial Endotoxin test.  
3.Sterile water for injection 5ml   Each glass ampoule contains Sterile water for injection 5ml    24L608  M/s Medisave Pharmaceuticals. Plot No.578-579 Sundar Industrial Estate Lahore. (DML # 000681)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of Bacterial Endotoxin test.  
4.Sterile water for injection 5 ml   Each glass ampoule contains Sterile water for injection 5ml25WF01  M/s Friends Pharma (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000681)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.  
5.ELPOMIDE INJ 10mg/2ml   Metoclopramide HCl BP 10mg/2ml  332  M/s Elite Pharma (Pvt) Ltd. 9.5 Km Sheikhupura Road Lahore. (DML # 000455)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.
6.Injection Aqua-P 5ml Each glass ampoule contains Sterile water for injection 5ml P-672  M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.  
7.Water for injection 5 ml Sterile water for injection 5ml.  130  M/s Wilshire Laboratories (Pvt) Ltd.  124/1 Industrial Estate Kot Lakhpat Lahore. (DML # 000232)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of Bacterial Endotoxin test.  
8.Sterile water for injection 10 ml   Each glass ampoule contains Sterile water for injection 10 ml  084L24  M/s Brookes Pharma (Pvt) Ltd.   Plot No. 58-59 Sector No. 15 Korangi Industrial Area Karachi. (DML # 000275)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of sterility test.  
9.Syrup Salbovent 60ml   Each 5ml contains: Salbutamol (as sulphate) …… 2mg  L25D52  M/s Synchro Pharmaceuticals.  77-Industrial Estate Kot Lakhpat Lahore. (DML # 575)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
10.Injection Vitamin K1   Each ml contains: Phytomenadione ……… 2 mg  H-18825  M/s Venus Pharma.  23 Km Multan Road Lahore. (DML # 000300)  DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of the result of sterility test.  
11.SNDOL Suspension 60 ml   Each 5ml contains:  Paracetamol ………. 120 mg  917  M/s S.N.B Pharma (Pvt) Ltd.   Plot No. 142 Industrial Estate Hayatabad Peshawar. (DML # 000759)  DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
12.Resgyl Suspension 60 ml   Benzoyl Metronidazole eq. to Metronidazole ……. 200mg / 5ml  4E566  M/s Rasco Pharma (Pvt) Ltd.  5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530)  DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
13.Syrup Syandin 60 ml   Each 5ml contains: Loratadine ………… 5 mg  L25E57  M/s Synchro Pharmaceuticals.  77-Industrial Estate Kot Lakhpat Lahore. (DML # 575)  DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
14.Injection Neocobal 1 ml Mecobalamin 0.5mg/ml  S-2621  M/s Pulse Pharmaceuticals (Pvt) Ltd.  Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)  DDCP Alert No. l73/2025 declared the sample as ‘substandard’ and ‘adulterated’.  
15.Infusion NIDA 100 ML Metronidazole 500mg/100ml  25D055  M/s GMP Pharmaceuticals. 28-Km Sheikhupura Road Lahore. (DML # 000815)  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.  
16.Metrorise injection Metronidazole 500mg/100ml  LV-2422  M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of Bacterial Endotoxin Test.  
17.Infusion Revasol-H 500ml (Hartmann solution)   Each 100 ml contains: Potassium Chloride 0.04gm, Sodium Lactate 0.32gm, Sodium Chloride 0.60gm, Calcium Chloride 2H20 0.027gm  25D1037  M/s Revive Pharmakon.   10-Km Raiwind Road Lahore. (DML # 000819)  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of Bacterial Endotoxin Test.  
18.Infusion Parapals 100 ml Paracetamol USP 1g/100ml  PPV-384  M/s Inventor Pharma. Plot No. K/196, S.I.T.E Phase-II, Karachi (DML # 000866)  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter.  
19.Injection Freclomide Metoclopramide …… 10mg/2ml  25MC05  M/s Friends Pharma (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000681).  DDCP Alert No. l77/2025 declared the sample as ‘substandard’ on the basis of visible particulate matter & Sterility test.  
20.Syrup Allerphene 120ml   Chlorpheniramine maleate ………………………2mg/5ml  4047  M/s P.D.H Pharmaceuticals (Pvt) Ltd.   19 Km Ferozepur Road Lahore. (DML # 000459)  DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of the result of impurity (ethylene glycol) above the permissible limits.  
21.Injection Aqua-P 5ml Sterile water for injection 5 mlP-676M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)  DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of the result of visible particulate matter & Bacterial Endotoxin Test.  
Risk Statement:The above-mentioned batches have been declared substandard due to serious quality defects including sterility failure, presence of bacterial endotoxins, visible particulate matter, and impurities such as ethylene glycol. Use of these defective medicines may lead to severe health risks including infections, sepsis, organ toxicity, or treatment failure.
This alert particularly concerns patients receiving ophthalmic preparations, sterile injections/infusions (including antibiotics, metronidazole, paracetamol, vitamin K, and electrolyte solutions), as well as children and adults using oral syrups and suspensions. Healthcare professionals and the general public are advised to immediately stop use of the affected batches and report any adverse events.
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 ProfessionalsDRAP 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.