"One lot of Petrem was recalled due to retained material not meeting the acidity/alkalinity specifications as set forth in the USP Monograph for Sevoflurane," United States Food and Drug Administration (USFDA) said.
The US health regulator said the recall of 2,052 glass vials of 250 ml was initiated in April under class III, which means use of or exposure to the product is unlikely to cause adverse health consequences.
Piramal Critical Care has product availability in more than 113 countries and is a part of the diversified Piramal Group that has operations in over 30 countries and brand- presence across 100 markets around the world.