Apollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues
Apollo Care is recalling 360 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Apollo Care is recalling 360 bags of Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag (NDC 71170-254-25). The recall is limited to Lot AC-015558 with an expiration date of 03/07/2018. The product was distributed to a medical facility in Missouri.
The recall was initiated because stability data does not support the 90-day beyond use date (BUD) assigned to the affected product. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities that received this product should stop using the affected lots and contact Apollo Care for instructions on return or disposal. Patients who have received this medication should contact their healthcare provider if they have questions or concerns.
The recalled product
- Product
- Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
- Manufacturer
- Apollo Care
- Category
- Drug — IV Infusion
- Affected units
- 360
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-015558
- Exp 03/07/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Apollo Care under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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