Rapid Alert
Falsified Sojourn ( Sevoflurane) Liquid For Inhalation
| DRAP Alert No | No II/S/07-23-27 |
| Action Date | 24th July 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. 4. General Public |
| Problem Statement | The federal Inspector of Drugs, Quetta, took sample of suspected Sojourn liquid for inhalation from two different batches and sent it for analysis to the laboratory. The Central Drug Testing Laboratory, Karachi declared these samples as “Spurious” based on the analysis. The laboratory also identified the differences in the labeling and packaging of the falsified products in comparison to the authorized pack of registered products. The product detail as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Batch # | Mfg. Date | Exp. Date | Manufactured by (as stated on label) | Remarks |
|---|---|---|---|---|---|---|
| 1 | Sojourn Liquid for Inhalation Reg.No. 088891 | S0502C11 S0512C14 | Mar-22 | Mar-27 | M/s Priamal Critical Care, Inc. USA | The sample is declared spurious for a non-complying identification test for Sevoflurane. Instead, lab identified chloroform in the samples. |
| Risk Statement: | Sojourn (Sevoflurane) Liquid is an inhalational anesthetic agent which is indicated for use in the induction and maintenance of general anesthesia. It may lead to life-threatening reactions as the safety, quality, and efficacy of the product are unknown. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products. -Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |
