Recall Alert
Lipidem® / Lipoplus® Emulsion for Infusion (Zone IV Stability Risk for Pakistan)
| DRAP Alert No | No I/S/09-25-65 |
| Action Date | 17 September, 2025. |
| Target Audience | · Hospitals (Public & Private): especially those with ICU, surgical, oncology, and nutrition support units. · Parenteral Nutrition Centre / Clinical Nutrition Teams: where lipid emulsions are routinely administered. · Pharmacists: particularly hospital pharmacists and those in charge of sterile/IV admixtures. · Physicians: especially intensivists, anesthesiologists, gastroenterologists, and pediatricians using parenteral nutrition. · Provincial Health Authorities & Regulatory Bodies: to ensure monitoring and enforcement at the provincial level. · Importer & Distributors: of Lipidem® / Lipoplus® in Pakistan. · Nursing Staff: involved in IV infusion preparation and administration. |
| Problem / Issue | Stability studies conducted by the manufacturer and German regulatory authority identified droplet-like agglomerates (subvisual fat particles) in Lipidem® / Lipoplus® emulsions stored at 25°C beyond 12 months. These agglomerates, if infused without appropriate filtration, may lead to serious adverse events, including fat embolism in pulmonary capillaries. The details of the product is as under: – |
Therapeutic Goods (s) Affected: –
| S# | Reg. # | Name of Drug(s) & Composition | Packing | Shelf Life | Importer details |
| 1. | 099492 | Lipoplus Emulsion for Intravenous Infusion Each 1000 ml contains: Medium chain triglycerides…. 100gm Soya oil …………………… 80gm Omega-3-acid triglycerides… ….20gm (As per Innovator’s Specification)* | 250m1 Glass Bottle | 02 years | M/s B.Braun Pakistan (Pvt) Ltd, The Forum, Suite 216 Khayaban-e-Jami, Clifton Block 9, Karachi. Godown address: Ground Floor Plot No. C-153, S-6F, Mehran Town, Karachi. |
| Risk Statement: | In stability studies conducted in Germany, droplet-like agglomerates were detected in Lipidem® / Lipoplus® emulsions stored at 25 °C beyond 12 months. To mitigate this risk under those conditions, the German authority recommended the use of a 1.2 µm lipid infusion filter during administration. Since Pakistan falls under Zone IV climatic conditions (hot and humid), which differ significantly from Germany (25°C), the risk of earlier onset of agglomerate formation cannot be excluded. To date, no stability information or scientific justification for Zone IV conditions has been provided by the manufacturer or Marketing Authorization Holder (MAH). Considering these factors and the higher temperature and humidity in Pakistan, the matter is classified as a Class I recall risk, as the defect may reasonably be expected to cause serious adverse health consequences if not managed appropriately. |
| 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. |