Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.
| DRAP Alert No | No I/S/11-25-109 |
| Action Date | 17 November, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory informed that the sample of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Zayzine Syrup Each 5 ml Contains: Cetirizine Dihydrochloride … 5 mg (Reg # 096969) | 25289 | M/s Zaynoon Pharmaceuticals (Pvt) Ltd. 27-28/B, Industrial Estate, Hayatabad, Peshawar (DML # 000358) | The sample has been declared Substandard on the basis of the Assay Test and Physical Description, as the syrup was found to be a clear, colourless liquid in an amber plastic bottle, whereas the manufacturer’s specification describes it as a light green, translucent, viscous, and sugar-free preparation. |
| Risk Statement: | As the product was found to contain excessive amount of the labeled active ingredient and to differ in appearance from the approved specifications. The excessive assay value indicates overdose of Cetirizine Dihydrochloride, which may cause drowsiness, dizziness, headache, or other antihistaminic side effects, particularly in children and sensitive individuals for whom this syrup is commonly prescribed. The defect therefore poses a potential risk to public health, especially in pediatric and allergic patients, and warrants a Class I recall of the affected batch to prevent further exposure and ensure patient safety. |
| 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. |