D-1262-2014 Class II Terminated

Recalled by Piramal Critical Care, Inc. — Bethlehem, PA

Recall Details

Product Type
Drugs
Report Date
May 7, 2014
Initiation Date
April 7, 2014
Termination Date
December 15, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,600 bottles

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.

Reason for Recall

Failed pH Specifications: product was too acidic.

Distribution Pattern

To wholesale distributors and retailers located Nationwide.

Code 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).