Sevoflurane Liquid
FDA Recall NDC 66794-015
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sevoflurane (NDC 66794-015). A significant event, classified as Class II, was initiated on Apr 07, 2014 by Piramal Critical Care Inc. The reported reason for this action was: "Failed pH Specifications: product was too acidic."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed pH Specifications: product was too acidic.
Apr 07, 2014
May 07, 2014
12,600 bottles
Recall Profile & Regulatory Data
Event ID
68004
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Piramal Critical Care, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
To wholesale distributors and retailers located Nationwide.
Termination Date
Dec 15, 2014
Product Description
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.
Batch or Lot Expiration Information
Lot# : S2611I28 (exp 9/16), S2511I14 (exp 9/16), S2531I16 (exp 9/16), S2721J21 (exp 10/16), S2871K03 (exp 11/16), S2881K03 (exp 11/16), and S2931K07 (exp 11/16).
Affected Packages Involved in this Recall
66794-015-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
