Amikacin Sulfate Injection — Class II drug recall D-0023-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2016-10-19, distributed nationwide. CGMP Deviations
| Recall number | D-0023-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2016-07-29 |
| Classified | 2016-10-12 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2018-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 27,547 vials |
| Reason classes | cgmp |
| NDC | 00703-9032-01, 00703-9032-03 |
| Lot numbers | 7080315, 7400315, 7410315, 7980415 |
Product
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
Reason for recall
CGMP Deviations
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-0023-2017. 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.