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 #: 4750915Exp 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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