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 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Reported: June 1, 2016 Initiated: March 9, 2016 #D-0859-2016
Product Description
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 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Reason for Recall
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 6,291 units
- Distribution
- Nationwide and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03. Recalled by Teva Pharmaceuticals USA. Units affected: 6,291 units.
Why was this product recalled? ▼
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2016. Severity: Critical. Recall number: D-0859-2016.
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