FDAClass IISeptember 14, 2016

ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 recall: CGMP Deviations

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…

Why was ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 recalled?

CGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots within Expiry. Lot # 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…
Recalling firm
Teva North America
Quantity
1,299 bags
Distribution
Nationwide and Puerto Rico
Recall date
September 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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