8 — Class I drug recall D-0865-2016
Ongoing recall by Hospira Inc., reported 2016-06-01, distributed nationwide. Presence of Particulate Matter: particulate matter identified as an insect in one vial.
| Recall number | D-0865-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-03-18 |
| Classified | 2016-05-23 |
| Reported by FDA | 2016-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 72,000 units |
| Reason classes | foreign material, specification failure |
| NDC | 00409-6625-02 |
| Lot numbers | 56-148-EV |
| Expiration dates | 2017-08-01 |
Product
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Reason for recall
Presence of Particulate Matter: particulate matter identified as an insect in one 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-0865-2016. 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.