The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0914-2017·Announced 2017-06-21

Pharmedium Recalls Vancomycin Bags With Incorrect Volume Labeling

Pharmedium Services is recalling 816 bags of Vancomycin HCl injection because the total volume was incorrectly labeled as 500 mL instead of 300 mL.

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 2/5 (Moderate).

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 minor labeling error regarding volume, which fits the rubric for moderate severity.

Plain-English summary

Pharmedium Services, LLC is recalling 816 bags of VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP. The recall is due to a labeling error where the total volume was printed as 500.00 mL on the product label, while the actual total volume is 300.00 mL.

The affected product is identified by NDC# 61553-043-34 and Service Code 2K2243. The recall covers specific lot numbers manufactured between February 22, 2017, and March 10, 2017. These products were distributed nationwide in the USA.

Healthcare providers and patients should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be quarantined and returned to the distributor or manufacturer according to standard recall procedures. This recall is classified as Class II by the FDA.

The recalled product

Product
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Manufacturer
Pharmedium Services, LLC
Category
Drug — Antibiotic Injection
Hazard
Affected units
816

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 (15)

  • Lot Numbers: 170200039S
  • 2/22/2017
  • 170230182S
  • 170230137S
  • 2/23/2017
  • 170260122S
  • 2/26/2017
  • 170300085S
  • 3/2/2017
  • 170320048S
  • 3/4/2017
  • 170340152S
  • 3/8/2017
  • 170380097S
  • 3/10/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Pharmedium Services, LLC 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 11 products in this recall →

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