The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0758-2020·Announced 2020-01-22

Recall of Assurance Infusion Morphine Injection for Sterility Concerns

Assurance Infusion is recalling Morphine 4mg/mL Injection in 20mL syringes due to lack of sterility assurance. The recall affects specific lots distributed nationwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for lack of sterility assurance in an injectable drug, presenting a risk of infection where injury has not yet been reported.

Plain-English summary

Assurance Infusion is recalling Morphine 4mg/mL Injection in 20mL syringes. The affected lots are 12112019@24 Exp. 12/20/2019; 12122019@1 Exp. 12/21/2019; and 12122019@2 Exp. 12/21/2019. The product was distributed nationwide within the United States.

The recall is due to lack of sterility assurance. This means the product may not have been manufactured under conditions that ensure it is free from contamination. Using non-sterile injectable medication can lead to serious infections.

Consumers who have the affected product should stop using it immediately and return it to the place of purchase or contact their pharmacist. They should consult a healthcare professional if they have any concerns. The recalling firm, Assurance Infusion, can be contacted for more information.

The recalled product

Product
MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable
Hazard
Affected units
3

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 (3)

  • Lots: 12112019@24 Exp. 12/20/2019
  • 12122019@1 Exp. 12/21/2019
  • 12122019@2 Exp. 12/21/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 118 recalled by Assurance Infusion 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 118 products in this recall →

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