Amikacin Sulfate injection USP — Class I drug recall D-0859-2016
Terminated recall by Teva Pharmaceuticals USA, reported 2016-06-01, distributed nationwide. Presence of Particulate Matter: particulate matter identified as glass in one vial.
| Recall number | D-0859-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2016-03-09 |
| Classified | 2016-05-23 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 6,291 units |
| Reason classes | foreign material, specification failure |
| NDC | 00703-9040-01, 00703-9040-03 |
| Lot numbers | 4750915 |
| Expiration dates | 2017-09 |
Product
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Reason for recall
Presence of Particulate Matter: particulate matter identified as glass in one vial.
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-0859-2016. 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.