The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0744-2020·Announced 2020-01-22

Assurance Infusion Recalls Hydromorphone Syringes Due to Sterility Concerns

Assurance Infusion is recalling specific lots of Hydromorphone 3mg/mL injection syringes due to a lack of sterility assurance. The products were 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 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Assurance Infusion is recalling two syringes of Hydromorphone 3mg/mL Injection in 20 mL syringes. The recall is being conducted because of a lack of sterility assurance in the product.

The affected lots are 12162019@14 with an expiration date of 12/25/2019, and 12102019@19 with an expiration date of 12/19/2019. These products were distributed nationwide within the United States.

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected lots and contact Assurance Infusion at (713) 533-8800 for further instructions.

The recalled product

Product
HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable
Hazard
Affected units
2

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 (2)

  • Lots: 12162019@14 Exp. 12/25/2019
  • 12102019@19 Exp. 12/19/2019

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 →

Related recalls

Same manufacturer · Assurance Infusion

See all →

Same hazard · sterility

See all →

Similar recalls