FDA Recall D-0859-2016
Teva Pharmaceuticals USA · North Wales, PA
Class I — life-threatening Terminated 335 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Recall record
- Recall number
D-0859-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- 2016-03-09
- Classified by FDA Center
- 2016-05-23
- FDA published
- 2016-06-01
- Terminated
- 2017-02-07
- Recalling firm
- Teva Pharmaceuticals USA
- Firm location
- North Wales, PA