Preservative-Free MORPHINE Sulfate Injection — Class II drug recall D-308-2013
Terminated recall by Hospira Inc., reported 2013-05-08, distributed nationwide. Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
| Recall number | D-308-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-08-28 |
| Classified | 2013-05-01 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 26,100 vials |
| Reason classes | sterility |
| NDC | 00409-3814, 00409-3814-11, 00409-3814-12, 00409-3815, 00409-3815-11, 00409-3815-12 |
| Lot numbers | 15-065-DK |
| Expiration dates | 2013-09-01 |
Product
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Reason for recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop 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-308-2013. 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.