Recall Alert: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

Recall Alert

DRAP Alert NoNo I/S/05-25-44
Action Date29th May, 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists
in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured byTest Results
Inflamac Injection

 
Reg. No. 036110
Each 3ml contains:
Diclofenac sodium…..75mg
25L-001M/s. Ipram International,
Plot No. 26, S.S-3, National Industrial Zone, Rawat, Islamabad.
‘Substandard’ on the basis of Visible particulates in injection.
ZOLREST INFUSION 300mL

 
Reg. No. 055916
Each 300ml vial contains:
Linezolid …….600mg
ZL250020M/s Bosch Pharmaceuticals (Pvt.) Ltd,
209, Sector 23, Korangi Industrial Area, Karachi.
‘Substandard’ on the basis of Bacterial Endotoxin Test.
LAKSOL-NS INFUSION 100mL

 
Reg. No. 110827
Each 100ml contains:
Sodium chloride…0.9g
3021489M/s Lakhani Pharma (Pvt) Ltd.,
Sheikh Zayed Road, Rahim Yar Khan, Pakistan.
‘Substandard’ on the basis of Bacterial Endotoxin Test. 
QAD-FEN 90ml Syrup


Reg. No. 121509
Each 5ml suspension contains:
Ibuprofen….100mg
LS0003M/s Qadir Pharmaceuticals,
Fateh Garh Sahuwala Road, Sialkot.
‘Substandard’ with regards to presence of impurity (Ethylene glycol), above the permissible limit.
BYTEC Tablet


Reg. No. 036183
Each film coated tablet contains:
Cetirizine dihydrochloride ..…..10mg
E089M/s. Batala Pharmaceuticals,
23/B, Small Industrial Estate # 2, Gujranwala.
‘Substandard’ with regards to Impurities test.
Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

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 gsmsdra.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.

Minutes of the 347th Meeting of the Registration Board Held on 28th – 30th APRIL, 2025

The Drug Registration Board convened its 347th meeting on 28th – 30th APRIL, 2025 in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.