The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0915-2017·Announced 2017-06-21

Pharmedium Recalls Vancomycin Injection Bags With Incorrect Volume Labeling

Pharmedium Services is recalling 60 bags of Vancomycin HCl injection because the label incorrectly states 500 mL instead of the actual 300 mL volume.

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 criteria for moderate severity.

Plain-English summary

Pharmedium Services, LLC is recalling 60 bags of VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP. The recall is due to a labeling error where the product label incorrectly printed the total volume as 500.00 mL, while the actual total volume is 300.00 mL.

The affected product is identified by Service Code 2K2237 and NDC# 61553-037-34. The specific lot numbers involved are 170160016S (dated 2/20/2017), 170240147S (dated 3/1/2017), 170380016S (dated 3/15/2017), and 170450010S (dated 3/22/2017). The product was distributed nationwide in the USA.

The FDA has classified this recall as Class II. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact Pharmedium Services for further instructions on how to return or dispose of the affected product.

The recalled product

Product
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, 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
60

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 (8)

  • Lot Numbers: 170160016S
  • 2/20/2017
  • 170240147S
  • 3/1/2017
  • 170380016S
  • 3/15/2017
  • 170450010S
  • 3/22/2017

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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