FDAClass IISeptember 14, 2016

Eptifibatide Injection 75 mg/100 mL recall: CGMP Deviations

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…

Why was Eptifibatide Injection 75 mg/100 mL 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# 2710715, 2720715, 2730715, 3110715, 3120715

Product
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…
Recalling firm
Teva North America
Quantity
14,661 vials
Distribution
Nationwide and Puerto Rico
Recall date
September 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls