Reported Jun 1, 2016 · Terminated

Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva…

Teva Pharmaceuticals USA

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505

Is this the product you have?

  • Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only
  • Manufactured in Hungary ForTeva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Lot codes and dates
    • Lot #: 4750915
    • Exp 9/2017
Amount recalled
6,291 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 7, 2017 · Data as of Sep 19, 6:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.