CLASS II Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Sevoflurane, USP (Inhalation Anesthetic) recalled
Piramal Critical Care is recalling Sevoflurane, USP (Inhalation Anesthetic), distributed nationwide in the US. The recall was initiated on 7 Apr 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1262-2014
- FDA event ID
- 68004
- Recalling firm
- Piramal Critical Care, Bethlehem, PA
- Brand
- Sevoflurane
- Manufacturer
- Piramal Critical Care Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2014
- FDA classified
- 25 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 7 Apr 2014 | Recall initiated by company | |
| 25 Apr 2014 | Classified by FDA | +18 days |
| 7 May 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed pH Specifications: product was too acidic.
Product as listed by the FDA
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.
Where it was distributed
To wholesale distributors and retailers located Nationwide.
Questions about this recall
Why was it recalled?
Failed pH Specifications: product was too acidic.
Which lots 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).
Where was it sold?
To wholesale distributors and retailers located Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Piramal Critical Care
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rocuronium Bromide Injection 50mg/ Multi-Dose Vial recalled | Piramal Critical Care | Other | Nationwide |
| Drug | CLASS II | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe recalledGablofen | Piramal Critical Care | Potency & Assay | Nationwide |
Other Sevoflurane recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sevoflurane, USP Inhalation Anesthetic recalled by Baxter HealthcareSevoflurane | Baxter Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS III | Ultane (sevoflurane), Inhalation Anesthetic recalled by AbbVieUltane | AbbVie | Packaging Defects | MS, OH |