The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0077-2017·Announced 2016-10-19

Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 935 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of reduced 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, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4; however, FDA Class II with potential loss of potency in a potent opioid medication is treated as Severe (4) due to the significant risk of therapeutic failure or adverse health consequences, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk scenarios.

Plain-English summary

Pharmedium Services, LLC is recalling 935 syringes of morphine sulfate, 0.5 mg per mL, in 0.9% sodium chloride, preservative free, 1 mL total volume, for IV use. The recall is being conducted because stability data does not support the expiry dates for the drugs packaged and stored in syringes.

The affected product is identified by product code 2R3119 and specific lot numbers with expiration dates between July 15, 2015, and October 12, 2015. The recall is classified as Class II by the FDA, indicating a situation that might cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or replacement. The recall is distributed nationwide.

The recalled product

Product
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
935

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 (20)

  • Lot Numbers: 15117038M
  • 151200111M
  • 15126052M
  • 15127038M
  • 15131015M
  • 15134028M
  • 15134031M
  • 15135049M
  • 151380104M
  • 15139033M
  • 15139063M
  • 151410121M
  • 15146038M
  • 15147041M
  • 15149045M
  • 15152036M
  • 151730212M
  • 151890291M
  • 151930131M
  • 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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