GENTAMICIN INJECTION — Class II drug recall D-0290-2015
Terminated recall by Fresenius Kabi USA, LLC, reported 2014-12-17, distributed nationwide. Defective Container: Vials may be missing stoppers.
| Recall number | D-0290-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Melrose Park, IL, United States |
| Recall initiated | 2014-11-12 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 92,125 vials |
| Reason classes | packaging |
| NDC | 63323-0010, 63323-0010-01, 63323-0010-02, 63323-0010-03, 63323-0010-20 |
| Lot numbers | 6107992 |
| Expiration dates | 2015-09 |
Product
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
Reason for recall
Defective Container: Vials may be missing stoppers.
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-0290-2015. 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.