The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0132-2018·Announced 2018-01-03

Pharmedium Recalls Hydromorphone Injection Due to Labeling Errors

Pharmedium Services LLC is recalling Hydromorphone HCl Injection due to incorrect or missing lot and expiration dates.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is limited to documentation and labeling issues.

Plain-English summary

Pharmedium Services LLC is recalling Hydromorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only. The recall was initiated because the product had incorrect or missing lot and/or expiration dates on the labeling.

The affected product is identified by Lot 172410025C and an expiration date of 11/27/2017. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injection
Hazard

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: 172410025C
  • Exp. 11/27/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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