5% Lidocaine HCL and 7 — Class III drug recall D-0169-2017
Terminated recall by Hospira Inc., reported 2016-12-14, distributed in PR. Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout
| Recall number | D-0169-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-06-29 |
| Classified | 2016-12-06 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2019-11-20 |
| Distributed | PR |
| Quantity | 287,200 |
| Reason classes | specification failure |
| NDC | 00409-4712-01 |
| Lot numbers | 03/17, 10/16, 34-547-DK, 34-548-DK, 39-372-DK |
Product
5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
Reason for recall
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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-0169-2017. 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.