April 2014 FDA Recall Drug by Piramal Critical Care, Inc.
D-1262-2014 - Failed pH Specifications

This Class II drug recall was voluntarily initiated by Piramal Critical Care, Inc. on April 7, 2014 for the product Drug. The FDA reported the reason for recall as failed ph specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1262-2014

Reason for Recall
Failed pH Specifications: product was too acidic.
Initiated
04-07-2014
Reported
05-07-2014
Quantity
12,600 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68004
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Piramal Critical Care, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
To wholesale distributors and retailers located Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-15-2014
Product Description About Product Description
Full technical description of the 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.

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

66794-015-25 Sevoflurane