Class II · Moderate risk Terminated
Amikacin 450MG IN NS 45ML
Reason Lack of sterility assurance
Amikacin Sulfate Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0703-9040-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0024-2017
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 I · High risk Terminated
Amikacin Sulfate injection USP
Reason Presence of Particulate Matter: particulate matter identified as glass in one vial.
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