Norepinephrine injectable recalled for lack of sterility assurance
Apollo Care is recalling Norepinephrine 4 mg dextrose injection (682 bags) due to lack of assurance of sterility. Distribution was limited to Missouri.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable medication with potential sterility contamination. No hospitalizations or illnesses reported. Meets the threshold for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Apollo Care, LLC is recalling Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection (NDC 71170-500-25) due to lack of assurance of sterility.
The affected product includes 682 bags with lot numbers AC-016640 (expiration 06/16/2023) and AC-016670 (expiration 08/29/2023). Distribution was limited to Missouri.
Norepinephrine is a prescription medication used to support blood pressure. Lack of sterility assurance in injectable products poses a risk of contamination. No illnesses or injuries have been reported to date.
Consumers and healthcare providers who have received this product should stop using it and contact Apollo Care, LLC or their healthcare provider for guidance on appropriate alternatives.
The recalled product
- Product
- 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
- Manufacturer
- Apollo Care, LLC
- Hazard
- sterility-assurance
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: AC-016640
- Exp. Date 06/16/2023
- AC-016670
- Exp. Date 08/29/2023
Distribution
Distribution scope not specified by the agency.
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