Mannitol I — Class II drug recall D-0831-2016
Terminated recall by Hospira Inc., reported 2016-04-27, distributed nationwide. Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
| Recall number | D-0831-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-03-08 |
| Classified | 2016-04-21 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2017-12-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | SG |
| Quantity | 22,292 bags |
| Reason classes | chemical contamination |
| NDC | 00409-7715-02 |
| Lot numbers | 10/16, 52-031-JT |
Product
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
Reason for recall
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
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-0831-2016. 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.