Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.
| DRAP Alert No | No II/S/12-25-120 |
| Action Date | 16 December, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories, Punjab 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. | Injection Neudex Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate: 4mg/ml (Reg. # 32876) | DX029, DX039, DX040, DX041, DX033, DX031, DX045, DX042, DX044, DX046, DX047, DX048, DX049, DX050, DX051, DX053, DX052, DX060, DX059. | M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576) | The sample is declared as “Adulterated” as per section 3 (iv) of The Drugs Act 1976. |
| 2. | Injection Ame-Pin Each 2ml contains: Tramadol HCI… 100 mg (Reg. # 065943) | TD-042 | M/s Ameer Pharma (Pvt) Ltd. 23-Km Sheikhupura Road, Lahore. (DML # 000604) | The sample “Sub-Standard” on the basis “Particulate contamination” visible particles” as per BP. |
| Risk Statement: | The use of Injection Neudex (Dexamethasone) declared as adulterated, and Injection Ame-Pin (Tramadol) found sub-standard due to visible particulate contamination, poses a serious risk to patient safety, particularly among critically ill patients, surgical patients, emergency care recipients, elderly individuals, and those with compromised immunity. Administration of adulterated or contaminated injectable products may result in treatment failure, severe allergic reactions, embolism, infections, organ toxicity, or even fatal outcomes. Healthcare professionals and patients are therefore urged to immediately discontinue use of the affected batches to prevent any potential adverse health consequences. |
| 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. |