Drug 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.
D-1262-2014
Product summary
- Event
- Event 68004
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,600 bottles
- Official record key
drug-enforcement:D-1262-2014
Official wording
Reason: Failed pH Specifications: product was too acidic.
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).
Distribution pattern: To wholesale distributors and retailers located Nationwide.
Derived failure modes
-
Unknown
Failed pH Specifications: product was too acidic.