Rifampin for Injection — Class II drug recall D-1234-2015
Terminated recall by Fresenius Kabi USA, LLC, reported 2015-07-22, distributed nationwide. Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
| Recall number | D-1234-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2015-06-04 |
| Classified | 2015-07-14 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 7,593 vials |
| Reason classes | specification failure |
| NDC | 63323-0351, 63323-0351-20 |
| Lot numbers | 6109469, 6109470 |
| Expiration dates | 2016-10 |
Product
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
Reason for recall
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
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-1234-2015. 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.