DRAP Recall Alert (Class-I): Substandard batch of Teczone forte injection has been recalled by DRAP
On February 25, 2026 Central Drug Laboratory Karachi (CDL) has reported that the sample of the Teczone Forte injection (batch number mentioned below) has been declared substandard following laboratory analysis. On receiving this report, Drug regulatory authority of Pakistan (DRAP) issued a class-I recall alert for the substandard batch of teczone forte injection.
Recall Class-I is a situation where there is enough evidence that the use of or exposure to a defective product can induce serious or permanent heatlh damage to the person or it even can cause death
DRAP Alert No.: I/S/02-26-05
Action Date: 25 February 2026
Target Audience
National Regulatory Field Force
Healthcare professionals
Physicians, pharmacists, and nurses working in hospitals and clinics
General public
Therapeutic Goods Affected
Product Name: Teczone Forte Powder for Injection
Composition (per vial):
Cefoperazone (as Sodium) â 1 g
Sulbactam â 1 g
Registration No.: 045516
Batch No.: 02
Manufacturer: SPL Pharmaceuticals (Pvt) Ltd.
Plot No. 4, Phase-III, Industrial Estate Hattar
DML No.: 000605
Reason for Declaration: The product has been declared substandard based on failure of the pH test of the reconstituted powder for injection.
Risk Statement
An abnormal pH level may affect the drugâs stability and therapeutic effectiveness and could pose safety risks to patients. Potential consequences include reduced treatment efficacy, irritation at the injection site, phlebitis, or systemic adverse reactions.
Patients at higher risk include hospitalized individuals receiving intravenous antibiotic therapyâparticularly those with severe infections such as sepsis, pneumonia, or intra-abdominal infectionsâas well as immunocompromised patients, elderly individuals, and critically ill patients in ICU settings. This product is administered parenterally in institutional healthcare facilities.
Actions Taken
The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned substandard batch of the medication.
Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.
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.
Guidance for Healthcare Professionals
 Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.
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Guidance for Consumers
Consumers must avoid this product. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.
Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.
Reference
Drug Regulatory Authority of Pakistan. (2026, February 25). 05. Recall Alert (Class-I) â CDL declared substandard â Teczone Forte Injection [Recall alert]. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/05-recall-alert-class-i-teczone-forte-batch-02-powder-for-injection/
Disclaimer
This content is shared solely for educational and public awareness purposes and is based on publicly available DRAP safety alerts and recall notices. It does not represent an official DRAP communication, medical advice, or regulatory directive. Readers consult qualified healthcare professionals before making any medical or regulatory decisions.
