Vancomycin IV Injection Recalled for Lack of Sterility Assurance
Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a theoretical quality-assurance issue rather than confirmed contamination, making this a precautionary recall.
Plain-English summary
Apollo Care LLC is recalling VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection (NDC 71170-184-25) due to lack of assurance of sterility.
Sterility assurance is critical for injectable medications. If the manufacturing process cannot guarantee that a product is free of microorganisms, there is a potential risk of infection if the product is administered to patients.
The recall affects 646 bags with the following lot numbers: AC-016633 (Exp. Date 05/24/2023) and AC-016651 (Exp. Date 07/22/2023). These products were distributed in Missouri only.
Healthcare providers and patients should stop using affected lots immediately and consult with their pharmacy or healthcare provider about alternative medications. Do not administer these products. Contact Apollo Care LLC or your pharmacy for product returns.
The recalled product
- Product
- VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
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-016633
- Exp. Date 05/24/2023
- AC-016651
- Exp. Date 07/22/2023
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
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27