Recalls / Class II
Class IID-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.
- Brand name
- Sevoflurane
- Generic name
- Sevoflurane
- Active ingredient
- Sevoflurane
- Route
- Respiratory (inhalation)
- NDC
- 66794-015
- FDA application
- ANDA077867
- Affected lot / code info
- 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).
Why it was recalled
Failed pH Specifications: product was too acidic.
Recalling firm
- Firm
- Piramal Critical Care, Inc.
- Manufacturer
- Piramal Critical Care Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3950 Schelden Cir, Bethlehem, Pennsylvania 18017-8936
Distribution
- Quantity
- 12,600 bottles
- Distribution pattern
- To wholesale distributors and retailers located Nationwide.
Timeline
- Recall initiated
- 2014-04-07
- FDA classified
- 2014-04-25
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1262-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.