Recall Alert
| DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES |
| DRAP Alert No | No I/S/06-26-35 |
| Action Date | 18 June, 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/Adulterated’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch | Manufacturers | Remarks |
| 1. | Neocobal 0.5 mg Injection Each ml contains: Mecobalamin ……..0.5mg (Reg. # 071447) | S-3052 | 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). |
| 2. | GAMMARAAS Injection Immune Globulin Injection (Human) 5%, 2.5g, 50ml/vial (Reg. # 031350) | 202311G042 | Imported & Distributed by Popular International (Pvt.) Ltd. 141, Justice Inamullah Road, Block 7 & 8 KMCHS, Karachi. | The sample is declared as “sub-standard” with regards to Description & Sterility test. |
| 3. | Injection. KAMEDEX 1mL Each ml contains: Dexamethasone Sodium Phosphate eq. to Dexamethasone phosphate 4 mg (Reg. # 074983) | DX-2642 | M/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). |
| 4. | BRZOLE 500mg/100ml Infusion Each vial contains: Metronidazole….500mg/100ml (Reg. # 099612) | 25055 | M/s Berlex Lab. International, 10-Km Nangshah Chowk Karachi Road Multan (DML # 000678) | The sample is declared as “sub-standard” with regards to Bacterial Endotoxin test. |
| 5. | Metrorise Infusion Metronidazole….500mg/100ml (Reg. # 040412-D) | LV-2514 | M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573) | The sample has been declared “Substandard” on the basis of Bacterial Endotoxin Test & Visible particles. |
| 6. | Murcobal Injection 500 mcg Each ml Contains Mecobalamin…500mcg (Reg. # 045904) | 109 | M/s Murfy Pharmaceuticals (Pvt) Ltd. 8-Km Raiwind Road Lahore. (DML # 000543) | 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). |
| 7. | Premvil Infusion 1gm/100 ml Each l00ml contains: Paracetamol………….1gm (Reg. # 125218) | PNO-2510 | Ahad International Pharmaceutical LTD 13-Km, Multan Road, Dera Ismail Khan | The sample is declared as “sub-standard” with regards to Visible Particulates |
| 8. | Aqua-P Injection Sterile water for injection 5ml | P-673 | M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551) | Sub-standard’ on the basis of Bacterial Endotoxin Test. |
| 9. | ZYOCAIN Gel Lignocaine Hydrochloride B.P 2% w/v (Reg # 012523) | 008 | M/s PharmaWise Labs (Pvt) Ltd. 25-M Industrial Area Kot Lakhpat Lahore. (DML # 000182) | Sub-standard’ on the basis of Sterility test |
| 10. | Injection Cara-Lac 30mg/1ml Each 1ml contains: – Ketorolac Tromethamine equivalent to Ketorolac………30mg (Reg. # 054997) | 25G022 | M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629) | The sample is declared as “sub-standard” on the basis of Test for Impurities i.e. Organic Impurities. |
| 11. | Sterile Water for Injection 5ml | 20334 | M/s NovaMed Pharmaceuticals (Pvt) Ltd. 28-Km Ferozepur Road Lahore (DML # 000590) | Sub-standard’ on the basis of Bacterial Endotoxin Test. |
| Risk Statement: | The affected products have been found to possess critical quality defects, including failure of sterility, bacterial endotoxin, assay, impurity, and visible particulate tests, while certain products were also declared adulterated due to misidentified active ingredients or misleading composition. Use of these products may result in treatment failure, serious infections, pyrogenic reactions, adverse health effects, or other patient safety risks. Healthcare professionals, distributors, and retailers are therefore advised to immediately cease distribution and use of the affected batches and ensure their prompt recall from the market. |
| 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. |