FDAClass IIMay 7, 2014

Sevoflurane recall

Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA…

Why was Sevoflurane recalled?

Failed pH Specifications: product was too acidic.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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).

Product
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA…
Recalling firm
Piramal Critical Care, Inc.
Quantity
12,600 bottles
Distribution
To wholesale distributors and retailers located Nationwide.
Recall date
May 7, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls