Key Takeaway
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. by Piramal Critical Care, Inc. was recalled on April 7, 2014. The hazard: Failed pH Specifications: product was too acidic.
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.
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.
Hazard / Reason
Failed pH Specifications: product was too acidic.
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
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.
DrugsCompany Information
Piramal Critical Care, Inc.
Bethlehem, PA, United States
View all 3 recalls by Piramal Critical Care, Inc. →Distribution
To wholesale distributors and retailers located Nationwide.
Related Recalls
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turk
September 10, 2021
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18
July 8, 2019
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.