The Recall Desk
ModerateFDA (Drugs)·D-0050-2017·Announced 2016-10-19

Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 1,916 syringes of Hydromorphone HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

What this means for you

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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or serious injuries are reported, and the hazard is a theoretical loss of potency rather than an acute physical danger.

Plain-English summary

Pharmedium Services, LLC is recalling 1,916 syringes of Hydromorphone HCl, 0.2 mg per mL (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume, For IV Use. The recall is being conducted because stability data does not support the expiration dates for the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication.

The affected product is identified by Product code 2R3162 and includes specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The product was distributed nationwide. Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be discontinued and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
1,916

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 (19)

  • Lot Numbers: 151200003M
  • 151260128M
  • 151300005M
  • 151310094M
  • 151320134M
  • 151320143M
  • 151340107M
  • 151370002M
  • 151390005M
  • 151390142M
  • 151400005M
  • 151400095M
  • 151400136M
  • 151470008M
  • 151510002M
  • 151520080M
  • 151880214M
  • 151890257M
  • 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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