Class II · Moderate risk Terminated
Amikacin 450MG IN NS 45ML
Reason Lack of sterility assurance
Amikacin Sulfate 250 mg/ml Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
What was recalled
Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Recalling firm
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-697-2013
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
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.