Vancomycin Injectable Antibiotic Recalled Due to Sterility Concerns
Apollo Care, LLC is recalling VANComycin 1.75 g injectable solution (NDC 71170-194-50) due to lack of assurance of sterility. The recall affects 240 bags 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 injectable drug recall involving a high-risk delivery method and a serious hazard (sterility failure). No illnesses or injuries are reported in the source text. Per the rubric, when the hazard is theoretical and no illnesses are reported, the score is at most 3. The injectable nature and sterility concern justify the High (3) classification rather than Moderate.
Plain-English summary
Apollo Care, LLC is recalling VANComycin 1.75 g in 0.9% Sodium Chloride Injection (NDC 71170-194-50) due to lack of assurance of sterility. The affected product consists of 240 bags with Lot #AC-016648, expiration date 07/01/2023, distributed only in Missouri.
Injectable medications must be free from contamination to prevent infection in patients. This recall is issued because the manufacturer cannot assure the sterility of the affected product.
Patients currently using this medication and healthcare providers should discontinue use of the recalled product. They should contact Apollo Care, LLC or their healthcare provider for guidance on replacement therapy and next steps.
The recalled product
- Product
- VANComycin 1.75 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 71170-194-50
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable / Antibiotic
- Hazard
- lack-of-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-016648
- Exp. Date 07/01/2023
Distribution
Distribution scope not specified by the agency.
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