FDA recall D-1262-2014

Piramal Critical Care, Inc. · Class II · drug

Product

Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25.

Reason for recall

Failed pH Specifications: product was too acidic.

Distribution

To wholesale distributors and retailers located Nationwide.

Key facts

Status: Terminated
Initiation date: 2014-04-07
Report date: 2014-05-07
Termination date: 2014-12-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1262-2014