FDA Recalls Apollo Care Norepinephrine Injections Due to Sterility Assurance Failure
Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg intravenous injection distributed in Missouri due to lack of assurance that the product meets sterility requirements.
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: This is a risk-of-harm product (injectable medication) where sterility is a critical safety requirement. The FDA classified it as Class II. No illnesses or injuries are reported in the source text; therefore, per the rubric, the score does not exceed 3.
Plain-English summary
Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection (NDC 71170-550-25) distributed in Missouri only.
The recall was issued because the manufacturer cannot assure that the product meets sterility requirements. Norepinephrine is a critical injectable medication administered in clinical settings; sterility is a required safety standard for all intravenous products.
The affected lots are AC-016631 (expiration date 05/29/2023) and AC-016655 (expiration date 08/07/2023). Healthcare facilities and providers in Missouri who received this product should verify their inventory against these lot numbers and contact Apollo Care, LLC for instructions on handling or replacement of affected stock.
The recalled product
- Product
- Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable Medication
- Hazard
- sterility-failure
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-016631
- Exp. Date 05/29/2023
- AC-016655
- Exp. Date 08/07/2023
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27