The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0710-2020·Announced 2020-01-22

Assurance Infusion Recalls BUP 4MG/FENT 3000MCG/ML Injection Due to Sterility Concerns

Assurance Infusion is recalling BUP 4MG/FENT 3000MCG/ML Injection in 20 mL syringes due to a lack of sterility assurance.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential hospitalization or significant injury risks associated with sterility failures in injectable drugs.

Plain-English summary

Assurance Infusion is recalling BUP 4MG/FENT 3000MCG/ML Injection in 20 mL syringes. The recall was initiated due to a lack of sterility assurance. The affected product is identified by Lot 12182019@7 with an expiration date of 12/27/2019.

The product was distributed nationwide within the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected product and contact Assurance Infusion at (713) 533-8800 for further instructions or a refund.

The recalled product

Product
BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable
Hazard
Affected units
1

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 (1)

  • Lots: 12182019@7 Exp. 12/27/2019

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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