Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.
DRAP Alert No | No II/S/10-25-99 |
Action Date | 22 October, 2025. |
Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
Problem / Issue | Central Drugs Laboratory Karachi informed that the sample of below mentioned drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
S# | Product Name | Batch No. | Manufacturers | Remarks |
1. | Zolint Suspension Each 5ml contains: FURAZOLIDONE…… 25 mg Metronidazole ………. 75 mg (Reg. # 016494) | 25024 | M/s Libra (Pvt) Ltd. 77 Industrial Estate Hayatabad Peshawar. (DML # 000369) | The sample has been declared ‘substandard’ on the basis of assay test of Furazolidone & Metronidazole. |
2. | Cytobion Capsule Each capsule contains: Mecobalamin …… 500 mcg (Reg. # 062462) | H575 | M/s Hoover Pharmaceuticals (Pvt) Ltd. Plot No.16 Zain Park Industrial Area Saggian By Pass Road Lahore. (DML # 000676) | The sample has been declared ‘substandard’ on the basis of description test wherein dark red crystals not found in sample while description is white capsule containing almost white fine powder with dark red crystals. |
Risk Statement: | The use of these defective medicines may result in therapeutic failure and ineffective treatment, particularly affecting vulnerable groups such as children, elderly, diabetic, and anemic patients. Substandard quality of Zolint Suspension used for infectious diarrhea may lead to prolonged illness, dehydration, and microbial resistance, while the defective Cytobion Capsule used for neuropathies and Vitamin B12 deficiency may cause delayed neurological recovery and worsening of deficiency symptoms. |
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. |