The Recall Desk
ModerateFDA (Drugs)·D-1562-2020·Announced 2020-09-16

Edge Pharma Recalls Vancomycin IV Bags Due to Labeling Error

Edge Pharma, LLC is recalling Vancomycin HCL 1.5 mg IV bags distributed in Wisconsin due to a label error regarding the declared strength.

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 and involves a labeling error with no reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Edge Pharma, LLC is recalling five IV bags of Vancomycin HCL 1.5 mg. The product is identified by NDC 05446-1458-01, Lot # 06-2020-04@2, and a best-use date of 09-16-2020. The recall is limited to distribution in Wisconsin.

The recall was initiated because of a labeling error on the declared strength of the medication. The source text does not specify the nature of the discrepancy or report any illnesses or injuries associated with the product.

Consumers and healthcare providers who have this specific lot of Vancomycin HCL should stop using it and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
Manufacturer
Edge Pharma, LLC
Affected units
5

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 (1)

  • Lot # 06-2020-04@2 BUD 09-16-2020

Distribution

Distributed in 1 state:

Same manufacturer · Edge Pharma, LLC

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