The Recall Desk
ModerateFDA (Drugs)·D-0615-2018·Announced 2018-04-04

Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date

Apollo Care is recalling 96 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The issue is a lack of stability data support for the expiry date, which is a quality control issue rather than a confirmed contamination or injury event.

Plain-English summary

Apollo Care is recalling 96 bags of Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag. The product is prescription-only and was distributed to a medical facility in Missouri. The specific lot number is AC-015569, with an expiration date of 03/26/2018.

The recall was initiated because stability data does not support the 90-day beyond use date (BUD) assigned to the affected product. This indicates that the product may not remain stable or effective for the full duration of the stated beyond use date.

Healthcare facilities that received this product should stop using the affected lot and contact Apollo Care for further instructions. Patients who have received this medication should consult their healthcare provider if they have questions or concerns.

The recalled product

Product
Vancomycin 1.25g added to 250 mL 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
96

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-015569
  • 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

See all →

Same hazard · stability

See all →