The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0076-2017·Announced 2016-10-19

Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 3,270 syringes of morphine sulfate due to stability data that does not support the expiry date, posing a potential 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 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, and the hazard is a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Pharmedium Services, LLC is recalling 3,270 syringes of morphine sulfate, 0.5 mg per mL, in 0.9% sodium chloride, preservative free (contains sulfites), 1 mL total volume in a syringe, for IV use. The recall is being conducted because stability data does not support the expiry date for the product, which may result in a potential loss of potency in drugs packaged and stored in syringes.

The affected product is identified by product code 2R3017 and includes lot numbers 15121035M, 15125026M, 15126061M, 15132040M, 15133041M, 15139084M, 15147038M, 15148024M, 15152044M, 151740022M, and 151900205M. The expiration dates for these lots range between 07/15/15 and 10/12/15. The product was distributed nationwide.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer for credit. Patients who have already received the medication should contact their healthcare provider for guidance.

The recalled product

Product
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
3,270

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: 15121035M
  • 15125026M
  • 15126061M
  • 15132040M
  • 15133041M
  • 15139084M
  • 15147038M
  • 15148024M
  • 15152044M
  • 151740022M
  • 151900205M
  • 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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