Ketamine Hydrochloride Injection — Class II drug recall D-0418-2015
Terminated recall by Hospira Inc., reported 2015-09-23, distributed nationwide. Defective Container: There were customer complaints of cracked and leaking glass vials.
| Recall number | D-0418-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-08-20 |
| Classified | 2015-09-15 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 83,320 vials |
| Reason classes | foreign material, packaging |
| NDC | 00409-2051-05 |
| Lot numbers | 43406DD, 44255DD |
| Expiration dates | 2016-07-01, 2016-08-01 |
Product
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
Reason for recall
Defective Container: There were customer complaints of cracked and leaking glass vials.
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-0418-2015. 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.