The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0051-2017·Announced 2016-10-19

Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 4,860 syringes of Hydromorphone HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

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, but the hazard is a theoretical loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 4,860 syringes of Hydromorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use. The product is identified by Product code 2R3352 and specific lot numbers with expiration dates between 07/15/15 and 10/12/15. The recall was initiated because stability data does not support the expiration dates for the drugs packaged and stored in syringes.

The primary hazard associated with this recall is the potential loss of potency in the medication. If the drug has lost potency, it may not provide the intended therapeutic effect for patients. The affected product was distributed nationwide.

Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or to arrange for a return or replacement. Consumers should not use the product if they have questions about its expiration date or integrity.

The recalled product

Product
HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
4,860

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 (12)

  • Lot Numbers: 15121069M
  • 15124075M
  • 15126078M
  • 15138012M
  • 15138013M
  • 15148077M
  • 15149122M
  • 15150103M
  • 151740201M
  • 151880159M
  • 151890210M
  • Exp between 07/15/15-10/12/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 69 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 69 products in this recall →

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