These batches of four drugs were recalled by Rwanda FDA over quality issue

By The Inspirer

The Rwanda Food and Drugs Authority (Rwanda FDA) has recalled from the Rwandan market six batches of four different drugs due to quality issue.

The drug batches in question are No:16222001 of Atropine Injection BP 1mg/ml, SA20C00SE  of Phytomenadione injection 10mg/ml; 3H20001; CH-1981; 3H20002 of Hyoscine butylbromide 20mg/ml; and Furosemide Injection BP 20mg/2ml’s JFDIE-001.

Atropine Injection BP 1mg/ml is a dug manufactured by Pharmax India Pvt Ltd, Phytomenadione injection 10mg/ml is by Infugen Pharma Pvt Ltd, India; Hyoscine butylbromide 20mg/ml manufacturer is Centurio N Healthcare Private Ltd, India, Furosemide Injection BP 20mg/2ml produced by Laborate Pharmaceuticals India Ltd.

The recall was decided based on the deep investigation and laboratory quality control tests performed by Rwanda FDA on suspected poor quality of the drugs in question, which confirmed that the reported medicines are of poor quality.

The quality issue with all the recalled medical product batches is the presence of visible particulates in tested vials, according to a circular dated May 25, which was signed by Dr. Charles Karangwa, Acting Director general of Rwanda FDA.

The circular was addressed to Rwanda Medical Supply Ltd (RMS Ltd), all Referral Hospitals, district hospitals, pharmaceutical wholesalers, importers, retail pharmacies and public and private health facilities.

What are the implicated drugs used for?

Atropine has many uses including being administered before general anaesthesia to reduce saliva secretions, and to restore normal heartbeat during a cardiac arrest.

For Phytomenadione, it is used in the treatment of haemorrhage (unusual bleeding), while Hyoscine butylbromide 20mg/ml is indicated for the treatment of spasms of the gastrointestinal tract and genitourinary tract.

Furosemide Injection is used to treating conditions including hypertensive crisis – a severe increase in blood pressure that can lead to a stroke – and acute or chronic renal failure.

Action to be taken against the batches in question

In the letter, the Rwanda FDA said it instructs all importers, central medical stores, wholesalers, RMS Ltd branches, retailers, as well as public and private health facilities to stop the distribution and dispensing of the above medical product batches and return them to their supplier for proper disposal.

“The importers and suppliers of the above incriminated batches of the above mentioned products are requested to report to Rwanda FDA within 10 working days the quantities imported, the quantities distributed, quantities returned and final stock at hand,” the circular reads in part.

 

The importation of the drug batches in question that are manufactured by the aforementioned manufacturers is suspended until they comply with Rwanda FDA product registration requirements, the circular warned.