Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date
Apollo Care is recalling 312 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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), particularly when involving potential adverse health consequences from compromised product stability.
Plain-English summary
Apollo Care is recalling 312 bags of Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag (NDC 71170-264-25). The recall is limited to Lot AC-015560 with an expiration date of 03/14/2018. 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.
Medical facilities that received this product should stop using the affected lot and contact Apollo Care for further instructions. Consumers should not use this prescription-only product and should consult their healthcare provider if they have questions regarding its use.
The recalled product
- Product
- Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25.
- Manufacturer
- Apollo Care
- Category
- Drug — IV Infusion
- Hazard
- Affected units
- 312
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-015560
- Exp 03/14/2018
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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