Teva North America recalls ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA
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Recall notice
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Source Page by GovInfoNow · govinfonow.com/recall/42584-teva-north-america-recalls-argatroban-injection-in-0-9-sodium · Recall date June 17, 2016 · FDA enforcement record: FDA #D-1494-2016
Cite this page
“Teva North America recalls ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA.” GovInfoNow, recall dated June 17, 2016. https://govinfonow.com/recall/42584-teva-north-america-recalls-argatroban-injection-in-0-9-sodium. Based on FDA recall #D-1494-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1494-2016%22&limit=1).
How to tell if you have this one
- Brand
Teva North America- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1494-2016 | 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).; All lots within Expiry. Lot # 4720915, 6790315, 6800315, 6810315, 6820315 | 1,299 bags |
| D-1495-2016 | Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers); All Lots Within Expiry | 92,480 containers |
| D-1496-2016 | Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.; All Lots Within Expiry Lot# 2710715, 2720715, 2730715, 3110715, 3120715 | 14,661 vials |
| D-1497-2016 | Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton); All Lots Within Expiry Lot # 2930614, 2940614, 2950614 | 13,223 vials |
Contact Teva North America
We’ve drafted a message you can send Teva North America to request your refund or repair — edit it as you like.
Subject: Recall D-1494-2016 — Teva North America Teva North America recalls ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/2 Hello, I own a Teva North America recalls ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA that is covered by recall D-1494-2016 from Teva North America. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1494-2016 (June 17, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1494-2016 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.