The Recall Desk
ModerateFDA (Drugs)·D-0079-2017·Announced 2016-10-19

Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 21,506 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of potency loss.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical loss of potency rather than a direct physical injury or contamination, fitting the criteria for a moderate severity score.

Plain-English summary

Pharmedium Services, LLC is recalling 21,506 syringes of morphine sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites). The product is intended for intravenous use and is available by prescription only. The recall covers specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015.

The recall was initiated because stability data does not support the expiry dates for the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication. 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. Consumers should verify the lot number and expiration date of their medication against the list provided in the official recall notice to determine if their product is affected.

The recalled product

Product
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.
Affected units
21,506

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: 15125021M
  • 15126043M
  • 15126064M
  • 15126065M
  • 15126066M
  • 15127091M
  • 15132014M
  • 15133011C
  • 15134006C
  • 15134007C
  • 15134062M
  • 15135063M
  • 15139087M
  • 15141002C
  • 15141040M
  • 15141041M
  • 15146081M
  • 15147036M
  • 15147037M
  • 15147122M

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 →