Bupivacaine Hydrochloride in 8 — Class II drug recall D-0076-2021
Terminated recall by Baxter Healthcare Corporation, reported 2020-11-18, distributed nationwide. Presence of particulate matter in solution - black and transparent particles
| Recall number | D-0076-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-10-07 |
| Classified | 2020-11-12 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2023-05-22 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 36000-0092-10 |
| Lot numbers | A0B1241, A0C0091, A0D0268 |
| Expiration dates | 2020-10, 2020-12, 2022-02 |
Product
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10
Reason for recall
Presence of particulate matter in solution - black and transparent particles
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-0076-2021. 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.