Drug 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 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
D-0859-2016
Product summary
- Event
- Event 73455
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6,291 units
- Official record key
drug-enforcement:D-0859-2016
Official wording
Reason: Presence of Particulate Matter: particulate matter identified as glass in one vial.
Code information: Lot #: 4750915, Exp 9/2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter