Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
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
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25
Affected NDC
71170-0500-25
Compare with the code on your package — it is the most precise check available.
Drug: Epinephrine
- Recalling firm
- Apollo Care, LLC
- NDC code
- 71170-500-25
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0644-2023 · 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.
Other Epinephrine recalls
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Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Other recalls by Apollo Care, LLC
All 2023 recalls
Class II · Moderate risk
SEMAGLUTIDE 20mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 10mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 7.5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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