Pakistan’s Drug Regulatory Authority (Drap) on Tuesday ordered the withdrawal of a batch of Anarob antibiotic drip after it was found to contain harmful levels of bacterial toxins.
Anarob Infusion is an intravenous antibiotic drip containing metronidazole, commonly used in hospitals to treat serious bacterial infections in the stomach, skin, lungs, joints, and other parts of the body when oral medicines are not effective.
A medical product alert issued today said Drap’s Central Drugs Laboratory had informed the body that samples of the drug were declared “substandard” due to being out of specification for bacterial endotoxins.
“Use of this contaminated infusion may cause severe adverse reactions such as fever, chills, septic shock and life-threatening complications. Hospitalised and immunocompromised patients are at the greatest risk,” the authority warned.
It said its field force and Provincial Drug Control departments were directed to immediately conduct market surveys to detect and remove the affected batch (H24219) from the market.
It further directed that the regulatory field force of all federating units should also increase surveillance in the market to ensure the effective recall of the defective product.
Drap also ordered that all pharmacists and chemists working at distribution centres and pharmacies should immediately check their stocks and stop supplying the drug, with the remaining stocks being quarantined and returned to the supplier/company.
The authority requested increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of the drug.
It instructed that any adverse reactions or quality problems experienced with the use of the drug be reported to the National Pharmacovigilance Centre (NPC), using the Adverse Event Reporting Form or the following link.
“Consumers should stop using products bearing the affected batch number and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drap/ National Pharmacovigilance Centre,” the alert concluded.
Last year in March, Drap directed a pharmaceutical company to recall a syrup, which is given to children to treat fever, from the market and advised health professionals not to prescribe it.
In January 2024, Drap directed pharmaceutical companies to recall nine contaminated syrups, according to its chief executive officer.
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