ARGATROBAN Injection in 0 — Class II drug recall D-1494-2016
Terminated recall by Teva North America, reported 2016-09-14, distributed nationwide. CGMP Deviations
| Recall number | D-1494-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva North America, Horsham, PA, United States |
| Recall initiated | 2016-06-17 |
| Classified | 2016-09-07 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,299 bags |
| Reason classes | cgmp |
| NDC | 00703-0020-31, 00703-0020-32 |
| Lot numbers | 4720915, 6790315, 6800315, 6810315, 6820315 |
Product
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
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-1494-2016. 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.