Class II · Moderate risk Terminated
Amikacin 450MG IN NS 45ML
Reason Lack of sterility assurance
Amikacin Sulfate injection USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: particulate matter identified as glass in one vial.
What 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
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0703-9040-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0859-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Amikacin recalls
See all
Class II · Moderate risk Terminated
Amikacin Sulfate Injection USP 1 gram/4mL
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Amikacin Sulfate Injection
Reason Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class II · Moderate risk Terminated
Amikacin Sulfate Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
Amikacin Sulfate Injection
Reason CGMP Deviations
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