Food, drugs, devices › Piramal Critical Care, Inc.
Drug recall: Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Sch
FDA enforcement event 68004 is a drug recall by Piramal Critical Care, Inc. of Bethlehem, PA, initiated 7 Apr 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 58% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 15 Dec 2014. Initiation: voluntary: firm initiated. Piramal Critical Care, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Piramal Critical Care, Inc., Bethlehem, PA.
Reason for recall
"Failed pH Specifications: product was too acidic."
Distribution
"To wholesale distributors and retailers located Nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1262-2014 | 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. | 12,600 bottles | Class II | Terminated | 7 May 2014 |
Context
Other enforcement events for Piramal Critical Care, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Sep 2021 | Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem | Drug | Class II | 1 |
| 8 Jul 2019 | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Di | Drug | Class II | 1 |
All 3 events for Piramal Critical Care, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed pH Specifications: product was too acidic."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "To wholesale distributors and retailers located Nationwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Dec 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.