Cefepime for Injection USP and Dextrose Injection USP — Class I drug recall D-1054-2014
Terminated recall by B. Braun Medical Inc, reported 2014-02-12, distributed nationwide. Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been foun
| Recall number | D-1054-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical Inc, Irvine, CA, United States |
| Recall initiated | 2013-10-15 |
| Classified | 2014-01-31 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 18,936 containers |
| Reason classes | specification failure |
| NDC | 00264-3193, 00264-3193-11, 00264-3195, 00264-3195-11 |
| Lot numbers | 01/15, H3A744 |
Product
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11
Reason for recall
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
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-1054-2014. 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.