FDA bans medicine for blood clot
MANILA, Philippines - The Food and Drugs Administration (FDA) has temporarily banned the sale of a medicine used to treat blood clot from India due to reported serious adverse reactions to the drug.
The FDA ordered the recall from the market of Heparin Sodium 1000 IU/ml solution for injection.
“In the interest of public safety, the FDA and Pharma-Surrey International Inc. will undertake a quality hold of all batches of Heparin Sodium,” it said.
The FDA said Heparin Sodium 1000 IU/ml solution for injection with brand names Diasea 5 and Meparin 5 are manufactured by Medchem International Ltd.
The pharmaceutical firm has initiated a recall of Meparin 5 with batch number N-3176 and registration number DRP-3912 due to reported serious adverse reactions to the drug, according to the FDA.
It ordered drug outlets and distributors to remove stocks of Heparin Sodium from their shelves.