The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0052-2017·Announced 2016-10-19

Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 450 syringes of Hydromorphone HCl because stability data does not support the expiry dates, posing a risk of loss of 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (loss of potency) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 450 syringes of HYDROmorphone HCl, 1 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 2T6165 and specific lot numbers: 15133058M, 15140061M, 15147056M, and 151880295M, with expiration dates between 07/15/15 and 10/12/15. The recall was initiated because stability data does not support the expiry dates for the drugs packaged and stored in syringes.

The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The primary hazard is a potential loss of potency in the medication. The affected units were distributed nationwide.

Healthcare providers and patients should discontinue use of the recalled syringes and contact Pharmedium Services, LLC for further instructions or replacement. Consumers should not attempt to use the product if they have questions regarding its stability or potency.

The recalled product

Product
HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
450

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 (5)

  • Lot Numbers: 15133058M
  • 15140061M
  • 15147056M
  • 151880295M
  • 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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