Class II · Moderate risk
Amikacin Sulfate Injection USP 1 gram/4mL
Lack of Assurance of Sterility
Amikacin 450MG IN NS 45ML
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320,
Drug: Amikacin
- Recalling firm
- Sentara Infusion Services
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0273-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Amikacin recalls
See all
Class I · High risk
Amikacin Sulfate Injection
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
Amikacin Sulfate Injection
CGMP Deviations
Class II · Moderate risk
Amikacin Sulfate Injection
CGMP Deviations
Class I · High risk
Amikacin Sulfate injection USP
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Other recalls by Sentara Infusion Services
All 2022 recalls
Class II · Moderate risk
VITAMIN K (Phytonadione)
Lack of sterility assurance
Class II · Moderate risk
Vancomycin
Lack of sterility assurance
Class II · Moderate risk
Vancomycin
Lack of sterility assurance
Class II · Moderate risk
TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM…
Lack of sterility assurance
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