Drug recall D-1262-2014
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.
Lots and codes
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).
Recall details
- Recalling firm
- Piramal Critical Care, Inc., Bethlehem, PA
- Quantity
- 12,600 bottles
- Distribution
- To wholesale distributors and retailers located Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 7, 2014
- Terminated
- December 15, 2014
Related products
- Sevoflurane – drug information
- NDC 66794-015 Sevoflurane · Sevoflurane 1 mL/mL · Piramal Critical Care Inc