FDAClass IJune 1, 2016

Amikacin Sulfate injection USP recall: Particulate Matter

Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA…

Why was Amikacin Sulfate injection USP recalled?

Presence of Particulate Matter: particulate matter identified as glass in one vial.

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?

Lot #: 4750915, Exp 9/2017

Product
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA…
Recalling firm
Teva Pharmaceuticals USA
Quantity
6,291 units
Distribution
Nationwide and Puerto Rico
Recall date
June 1, 2016
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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