Injectable Vancomycin Recalled Due to Lack of Sterility Assurance
Apollo Care LLC is recalling 1,113 bags of VANComycin injectable solution due to lack of assurance of sterility. The recalled product was distributed in 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: This is an FDA Class II recall of a sterile injectable product with no reported illnesses or injuries. The hazard—lack of sterility assurance—represents a risk of harm to patients, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Apollo Care LLC is recalling VANComycin 1.25 grams in 250 mL bags of 0.9% Sodium Chloride Injection (NDC 71170-264-25) due to lack of assurance of sterility. A total of 1,113 bags from Lot AC-016647 with an expiration date of June 28, 2023, have been recalled.
Sterility is a critical requirement for injectable pharmaceuticals. The manufacturer was unable to provide adequate assurance that all units maintained sterile conditions during manufacture, storage, and distribution.
The recalled product was distributed in Missouri only. Healthcare providers and patients who have received this product should consult with their healthcare provider regarding any health concerns. Persons with unused product should contact Apollo Care LLC at their Columbia, Missouri facility.
The recalled product
- Product
- VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25
- Manufacturer
- Apollo Care, LLC
- Hazard
- sterility
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 (2)
- Lot #: AC-016647
- Exp. Date 06/28/2023
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
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- SevereBortezomib for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- ModerateGasco Isopropyl Alcohol 70% recalled nationwide for subpotency
FDA (Drugs) · 2026-07-15