D-1262-2014 Class II Terminated
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).