BUPivacaine HCl 0 — Class II drug recall D-1422-2014
Terminated recall by Healix Infusion Therapy, Inc., reported 2014-07-16, distributed in TX. Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.2
| Recall number | D-1422-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Healix Infusion Therapy, Inc., Sugar Land, TX, United States |
| Recall initiated | 2014-02-13 |
| Classified | 2014-07-07 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2016-02-16 |
| Distributed | TX |
| Quantity | 10 bags |
| Reason classes | foreign material, specification failure |
| NDC | 75901-7210-53 |
| Lot numbers | 6156-0 |
| Expiration dates | 2014-03-07 |
Product
BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.
Reason for recall
Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1422-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.