The Recall Desk
SevereFDA (Drugs)·D-0614-2018·Announced 2018-04-04

Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date

Apollo Care is recalling 144 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 source text identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when the agency's own classification is provided.

Plain-English summary

Apollo Care is recalling 144 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-015565 with an expiration date of 03/26/2018. 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 providers and patients should discontinue use of the affected product and contact Apollo Care for further instructions or a replacement.

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 Solution
Hazard
Affected units
144

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-015565
  • Exp. 03/26/2018

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Apollo Care

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Same hazard · stability issue

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