FDA Drug recall D-0023-2017
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales,…
- FDA Drug
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales,… by Teva Pharmaceuticals Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0023-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-29 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
CGMP Deviations
Identifiers
| code_info | Lot # 7080315, 7400315, 7410315, 7980415 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0023-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.