Glenmark recalls hypertension medicine in the US over manufacturing issues
What's the story
Glenmark Pharmaceuticals and FDC Ltd are recalling certain products from the US market on account of manufacturing defects, the US Food and Drug Administration (USFDA) reported.
The recall includes a generic hypertension medication by Glenmark and a glaucoma treatment drug by FDC.
The US health regulator's enforcement report revealed that the recalls were initiated on January 22 and January 23 respectively.
Company #1
Glenmark recalls hypertension medication
Glenmark Pharmaceuticals Inc, USA, a subsidiary of Mumbai-based Glenmark Pharmaceuticals, is recalling Carvedilol tablets of 25mg and 12.5mg strengths from the US market.
The recall was initiated after N-Nitroso Carvedilol I impurity (NNCI-I) levels were found to be exceeding the current FDA recommended limit.
The US health regulator disclosed this information in its latest enforcement report.
Company #2
FDC recalls 1,18,104 bottles of glaucoma treatment drug
FDC Ltd is recalling 1,18,104 bottles of Timolol Maleate ophthalmic solution USP, a drug used for treating glaucoma.
The recall was initiated due to a "Defective Container," the USFDA said. The issue with the container was that users were unable to dispense the solution as the cap's spike got stuck in the product bottle's nozzle.
This drug was manufactured at FDC Ltd's Aurangabad facility.
Recall impact
Understanding implications of a Class II recall
The USFDA categorizes these recalls as Class II. This means that the use or exposure to these products may cause temporary or medically reversible adverse health effects. However, the risk of serious adverse health effects is low in such cases.