Rifampin for Injection USP — Class III drug recall D-1571-2014
Terminated recall by Akorn, Inc., reported 2014-10-01, distributed nationwide. Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the
| Recall number | D-1571-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-08-05 |
| Classified | 2014-09-22 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 5,539 vials |
| Reason classes | specification failure |
| NDC | 17478-0151-42 |
| Lot numbers | 12RIF4A |
| Expiration dates | 2014-09-30 |
Product
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
Reason for recall
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
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-1571-2014. 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.