Recall Alert
| DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES |
| DRAP Alert No | No I/S/05-26-26 |
| Action Date | 04 May, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories (DTL) Punjab informed that the samples of below mentioned drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch | Manufacturers | Remarks |
| 1. | ZYOCAIN Gel Lignocaine Hydrochloride B.P 2% w/v (Reg # 012523) | G026 | M/s PharmaWise Laba. (Pvt.) Ltd. Formerty Fakma Pharma 25-41 QA Induatrial Estate, Lahore-Pakistan (DML # 000182) | The Sample is declared as “sub-standard” on the basis of Sterility Test. |
| 2. | Neocobal Injection 0.5/mg Each ml contains: Mecobalamin……..0.5mg (Reg # 071447) | S-3050 | M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564) | The sample is declared as “sub-standard” on the basis of Assay Test & “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Cyanocobalamin is Identified). |
| 3. | Injection Neutroline 10 ml Water for injection 10ml (Reg # 096698) | L387 | M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576) | The Sample is declared as “sub-standard” on the basis of Endotoxin Test. |
| 4. | CARA-DOBA Injection Each 5mL ampoule contains Dobutamine HCL USP Eq to Dobutamine …. 250mg (Reg # 054987) | 25E004 | M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629) | The sample is sub-standard, on the basis “Physical description” and “Visible particulate matter” tests. |
| 5. | PAINSTOP Injection Each 3ml contains Diclofenac Sodium B.P………75mg (Reg # 023730) | PS-090, PS-091 | M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342) | The above sample is sub-standard on the basis “Physical Description-Visible Particulate matter”. |
| 6. | SENSOCAIN Injection Each ml contains: Bupivacaine Hydrochloride …. 5 mg (Reg # 047396) | 172K25 | M/s Brookes Pharma Private Limited 58-59 Sector 15 Korangi Industrial Area Karachi. (DML # 000275) | The sample is sub-standard on the basis of Sterility test. |
| 7. | Tablet Kadin 2 mg Each Tablet Contains Tizanidine (as Hydrochloride) … 2mg (Reg # 033347) | 570 | M/s FYNK Pharmaceuticals. 19-Km Ferozepur Road G.T. Road Kala shah Kaku Lahore. (DML # 000494) | The sample is declared as “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Paracetamol identified). |
| 8. | Infusion. GEE-SOL NS 1000ML Sodium Chloride 0.9% w/v (Reg # 080418) | 26A025 | M/s Gallop Water Sciences, 404-Sundar Industrial Estate, Lahore. (DML # 000817) | The sample is sub-standard, on the basis of Bacterial Endotoxins Test. |
| 9. | Infusion. GEE-SOL RL 500ml (Compound Sodium Lactate) (Reg # 080910) | 25MM264 | M/s Gallop Water Sciences, 404-Sundar Industrial Estate, Lahore. (DML # 000817) | The sample is sub-standard, on the basis of Bacterial Endotoxins Test. |
| Risk Statement: | The identified products present moderate to high public health risk, particularly because several are parenteral (injectable/infusion) preparations, which bypass natural body defenses. Failures in sterility and endotoxin tests (e.g., ZYOCAIN Gel, SENSOCAIN, Neutroline, GEE-SOL infusions) can lead to sepsis, pyrogenic reactions, or life-threatening infections, especially in hospitalized, immunocompromised, pediatric, and ICU patients, who are the most vulnerable. Products with visible particulate matter (CARA-DOBA, PAINSTOP) pose risks of embolism, inflammation, and organ damage. Adulterated medicines (Neocobal, Kadin) indicate serious quality breaches, potentially causing therapeutic failure, unexpected pharmacological effects, or toxicity, undermining clinician trust and treatment outcomes. The most likely affected population includes inpatients in public/private hospitals, emergency care recipients, and patients receiving IV therapy, where such products are commonly used. Overall, these defects reflect critical lapses in manufacturing quality systems, with the highest risk concentrated in injectables and infusions used in acute care settings. |
| 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. |