VANComycin Injectable Recalled for Lack of Sterility Assurance
Apollo Care, LLC is recalling a VANComycin injectable medication due to lack of assurance of sterility. The affected lot was distributed in Missouri only.
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 Class II recall of an injectable medication with lack of sterility assurance. While no illnesses have been reported, the product represents a risk-of-harm situation where a compromise in sterility directly threatens patient safety, meeting the rubric criterion for High severity.
Plain-English summary
Apollo Care, LLC is recalling 54 bags of VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The affected product was distributed in Missouri only.
The recalled lot is identified as AC-016649 with an expiration date of 07/01/2023. Because the sterility of this injectable medication cannot be assured, patients who received this product should contact their healthcare provider to discuss any concerns.
Non-sterile injectables can pose a risk of serious infection. Healthcare providers should verify whether any patients they are treating may have received this product from the affected lot.
The recalled product
- Product
- VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable
- Hazard
- sterility
- infection-risk
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-016649
- Exp. Date 07/01/2023
Distribution
Distribution scope not specified by the agency.
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