Rapid Alert; Drug Product: Falsified Sojourn ( Sevoflurane) Liquid For Inhalation

Rapid Alert

Falsified Sojourn ( Sevoflurane) Liquid For Inhalation

DRAP Alert NoNo  II/S/07-23-27
Action Date24th July 2023
Target Audience1. 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 StatementThe 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:-

SrProduct NameBatch #Mfg. DateExp. DateManufactured by
(as stated on label)
1Sojourn Liquid for Inhalation
Reg.No. 088891
Mar-27M/s Priamal Critical Care, Inc. USAThe sample is declared spurious for a non-complying identification test for Sevoflurane.  Instead, lab identified chloroform in the samples.
*The differences noted in the labeling and packaging of sample products declared as spurious in comparison to the authorized product from the marketing authorization holder are summarized in a table as Annexure-I.
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 InitiatedThe 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 ConsumersConsumers 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.