Teva Recalls Argatroban Injection Due to CGMP Deviations
Teva North America is recalling specific lots of Argatroban Injection in 0.9% Sodium Chloride due to Current Good Manufacturing Practice deviations.
Use caution until it’s fixed
CGMP Deviations
Contact the company
What happened, in plain English
Teva North America is recalling approximately 1,299 bags of Argatroban Injection in 0.9% Sodium Chloride (250 mg/250 mL) because the product was manufactured with deviations from Current Good Manufacturing Practices (CGMP). The recall affects specific lots distributed nationwide and in Puerto Rico. The record does not specify a remedy or indicate that the product has been returned or discarded. Read more at govinfonow.com/recall/42584-teva-recalls-argatroban-injection-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/42584-teva-recalls-argatroban-injection-due-to-cgmp-deviations · Updated October 9, 2026 · FDA enforcement record: FDA #D-1494-2016
Cite this page
“Teva Recalls Argatroban Injection Due to CGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42584-teva-recalls-argatroban-injection-due-to-cgmp-deviations. Based on FDA recall #D-1494-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1494-2016%22&limit=1).
Why it’s dangerous
The recall is due to CGMP deviations during manufacturing. While the record does not explicitly state the specific nature of the deviation or the resulting risk to patients, CGMP issues can potentially affect product quality, sterility, or potency.
Who’s affected
Patients who have received or possess Argatroban Injection from the affected lots, particularly those in the United States and Puerto Rico. Healthcare providers handling these specific batches are also directly involved.
How to tell if you have this one
Check for Argatroban Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL), Rx Only. Look for NDC# 0703-0020-31 (Single Use Bag) or NDC # 0703-0020-32 (5 Single Use Bags in One Carton). Affected lots are 4720915, 6790315, 6800315, 6810315, and 6820315.
- Brand
Teva- 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 |
What to do — step by step
Identify Affected Lots
Verify if your Argatroban Injection bags match the NDC numbers and lot numbers listed in the recall record.
Consult Healthcare Provider
Contact your doctor or pharmacist to determine if you have received any of the recalled product and what steps they recommend.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
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.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- 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.