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131. Recall Alert (Class-II) – DTLs Punjab Declared Substandard products.

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DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.

DRAP Alert NoNo II/S/01-26-131
Action Date14 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 Provinces informed that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.Tablet. Megadip Each tablel contains: Amlodipine as Besylate USP…. 5mg (Reg. # 071447)25F278M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)The samples have been declared Sub-standard with regards to Impurities test.
2.Tablet Ascard 75 mg Each Enteric Coated Tablet contains: Aspirin 75 mg (Reg # 016600)AR049LM/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)The samples have been declared Sub-standard with regards to Test for Related substances (Impurity C: Salicylic Acid).
4.Tablet CENEX 10 mg Cetirizine dihydrochloride 10mg (Reg # 032103)422  M/s Dr. Raza Pharma.  Road B-4 P.No 44-C Indus: Estate Jamrud Road Peshawar. (DML # 000387)The sample is declared as “Sub-Standard” on the basis of test for Impurities i.e. Organic Impurities.
5.Tablet Valron-P Each Sugar Coated Tablet contains: Diclofenac Sodium …. 50 mg (Reg # 030760)T-03624M/s Venus Pharma.   23 Km Multan Road Lahore. (DML # 000300)The sample is declared as “Sub-Standard” on the basis of Disintegration and Dissolution Test.
Risk Statement:The presence of excessive impurities, toxic contaminants, and performance failures in Megadip (amlodipine), Ascard (aspirin), Entagyl suspension (metronidazole), Cenex (cetirizine), and Valron-P (diclofenac) poses a significant risk to patient safety. Elevated levels of impurities, including salicylic acid, organic impurities, and ethylene glycol, may lead to toxicity, organ damage, allergic reactions, and gastrointestinal or neurological complications, while poor disintegration and dissolution can cause treatment failure or unpredictable dosing. The public most likely to be affected includes patients with heart disease, hypertension, infections, allergies, and chronic pain, particularly elderly patients, children, and those with kidney, liver, or cardiovascular disorders, where compromised medicine quality may result in serious and potentially life-threatening 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 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.

    130. Recall Alert – Drug Testing Laboratories, Punjab – Substandard products.

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    DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

    DRAP Alert NoNo I/S/01-26-130
    Action Date14 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 NameBatch No.ManufacturersRemarks
    1.Injection Neocobal Mecobalamin: 0.5 mg/ML (Reg. # 071447)S-2901M/s Pulse Pharmaceuticals (Pvt) Ltd.  Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)The samples have been declared Sub-standard with regards to Assay and Adulterated as per Section 3 (a) (v) of The Drugs Act 1976.
    2.Injection Kamedex 1 ml Each ml contains: Dexamethasone Sodium Phosphate eq. to Dexamethasone phosphate …… 4 mg (Reg. # 074983)  DX-2485M/s Amaan Pharma.  30-Km Sheikhupura Road Lahore  (DML # 000808)The sample has been declared Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (label claims Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4 mg/mL, laboratory analysis identified Dexamethasone base at a much lower level, rendering the composition false and misleading).  
    3.Unisol NS Infusion 100ml Each 100 ml contains: Sodium Chloride …. 0.9g5109040M/s Unisa Pharmaceutical Industries Ltd.  Main GT Road Adamzai Akora Khattak District Nowshera. (DML # 000740)The sample has been declared Sub-standard on the basis of Bacterial Endotoxin test.
    4.Isobaj Injection 10ml Each ml contains: Isosorbide Dinitrate ……. 1mg (Reg # 100721)IB-1125M/s Bajwa Pharmaceuticals (Pvt) Ltd. 36-Km Lahore Gujranwala Road Khori District Sheikhupura. (DML # 000805)The sample is declared as “Sub-Standard” on the basis of Bacterial Endotoxins Test (BET) & “Misbranded” as per section 3 (s) (iv) of the Drugs Act 1976.  (sample does not comply with definition of BP monograph of “Isosorbide Dinitrate Injection” which states that “It is supplied as a ready-to-use solution”. While label mentions “Must be Diluted Prior to use on primary as well as secondary package of sample, that is contradictory with definition. Therefore, the sample is MISBRANDED).  
    5.Infusion ZEESOL-H (RINGER LACTATE) Each 1000 ml contains: Calcium chloride 2H2O 0.27gms, Potassium Chloride 0.40 gms, Sodium Chloride 6.00gms, sodium lactate 3.20gms water for injection q.s (Reg # 019752)  2503281M/s Shazeb Pharmaceutical Industries Ltd.  Hazara Trunk Road Sarai Gadaee Dist.: Haripur. (DML # 000380)The sample has been declared Sub-standard on the basis of Sterility test.
    6.Injection Neudex Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate: 4mg/ml  (Reg. # 32876)DX079, DX080, DX064, DX060, DX042, DX063, DX072, DX067, DX068, DX070, DX065M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)The sample has been declared Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (label claims Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4 mg/mL, laboratory analysis identified Dexamethasone base at a much lower level, rendering the composition false and misleading).
    7.Entagyl Oral Suspension 400ml Each 5ml suspension contains: Benzoyl Metronidazole equivalent to 200mg of Metronidazole BP. (Reg # 087947)  272M/s BJ Pharmaceuticals. Mandialai Stop Bhattianwala Road 18-Km Lahore Sheikhupura Road, Lahore. (DML# 000770)The sample is Sub-Standard with regards to presence of impurity (Ethylene Glycol), above the permissible limit.
    Risk Statement:The identified quality defects in Neocobal Injection (mecobalamin), Kamedex Injection (dexamethasone), and Unisol NS Infusion present a serious risk to patient safety. Sub-standard potency and adulteration in injectable medicines may lead to treatment failure, incorrect dosing, and unpredictable clinical response, while contamination with bacterial endotoxins can cause fever, shock, and life-threatening reactions. The public most likely to be affected includes hospitalized patients, emergency and critically ill patients, children, pregnant women, and patients receiving steroid therapy, vitamin B12 injections, or intravenous fluids, where even small deviations in quality can result in severe and potentially fatal 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 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.

      129. Recall Alert(Class-I) – DIFAM Injection 3ml (Bosch Pharma) – Substandard

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      Recall Alert

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      DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

      DRAP Alert NoNo II/S/01-26-129
      Action Date14 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 NameBatch No.ManufacturersRemarks
      1.DIFAM Injection 3ml Diclofenac Sodium (75mg/3ml) (Reg. # 014651-EX)D260005, D260006M/s Bosch Pharmaceuticals (Pvt) Ltd. (DML # 000707)  Plot No. 209 Sector 23 Korangi Industrial Area Karachi.The samples have been declared  “Sub-Standard” on the basis  of assay test.
      Risk Statement:Use of a sub-standard injectable diclofenac may lead to therapeutic failure or overdose-related toxicity, including inadequate pain and inflammation control, gastrointestinal bleeding, kidney injury, cardiovascular complications, and injection-site reactions. The groups most likely to be affected include patients receiving injections for acute pain, post-operative pain, arthritis, trauma, and emergency care, particularly elderly patients, individuals with kidney, heart or gastric disease, and hospitalized patients, where incorrect dosing may result in serious and potentially life-threatening 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 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.

        128. Rapid Alert – Eventone-C Creams & LUFA Advanced Pain Relief Gel Containing Unauthorized Pharmaceutical Ingredient(s)

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        Rapid Alert

        Unregistered and Falsified Cosmetic Cream Containing Unauthorized Pharmaceutical Ingredient(s)

        DRAP Alert NoNo I/S/01-26-128
        Action Date14 January , 2026
        Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
        2. Healthcare Professionals
        3. Pharmacies and medical stores
        Problem StatementCentral Drugs Laboratory (CDL) Karachi informed that Laboratory analysis of Below mentioned Cream, marketed for skin fairness and treatment of skin darkness (cosmetic products) & a Gel marketed for pain relief, confirmed the presence of steroids (prescription-only corticosteroid). These products were being marketed as a cosmetic without declaring this pharmaceutical ingredient and without registration or authorization from the Drug Regulatory Authority of Pakistan (DRAP).
        The presence of a potent medicinal substance in a cosmetic product constitutes misrepresentation of identity, composition, and regulatory status, rendering the product an Unregistered and Falsified Drug Product under the Drugs Act, 1976.

        The product identification d

        S#Product NameBatch No.ManufacturerRemarks
        1.Eventone-C Cream12706M/s Pharma Health Pakistan Pvt. Ltd.  The sample has been declared “Un-registered/falsified” under the Drugs Act 1976 because Hydrocortisone has been identified as suspected by Federal Inspector of Drugs.  
        2LUFA Advanced Pain Relief Gel25C372M/s ASR Global Traders  The sample has been declared “Un-registered/falsified” under the Drugs Act 1976 because Betamethasone has been identified as suspected by Federal Inspector of Drugs.  

        etails are as under: –

        Risk StatementThe identification of hydrocortisone in Eventone-C Cream and betamethasone in LUFA Advanced Pain Relief Gel, both of which are prescription-only corticosteroids, in products being marketed without registration or authorization poses a serious public health risk. Use of these substances without medical supervision may result in skin thinning, steroid-induced acne, pigmentation disorders, delayed wound healing, suppression of local immunity, masking of infections, and worsening of underlying skin diseases. As these products are falsely presented as ordinary cosmetic and topical preparations, users are unknowingly exposed to potent pharmaceutical agents, increasing the risk of prolonged misuse, dependency, and irreversible skin damage, particularly in women, children, and long-term users.

        Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersParents, caregivers, pharmacies, retailers, and online sellers are strongly advised to immediately check product names and batch numbers, stop use and sale of affected batches, and remove them from circulation. Consumers who have already used these products and observe any adverse symptoms in infants should seek immediate medical attention and report the case to the relevant health authority.
        This alert is issued in the interest of public health and infant safety, and dissemination through healthcare facilities, pharmacies, online platforms, and social media is strongly recommended.