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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.