The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0688-2020·Announced 2020-01-22

Assurance Infusion Recalls BUP 1MG//ML/HYDROM 7MG Injection Due to Sterility Concerns

Assurance Infusion is recalling BUP 1MG//ML/HYDROM 7MG Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.

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, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Assurance Infusion is recalling BUP 1MG//ML/HYDROM 7MG Injection in 20 mL syringes. The recall is being conducted due to a lack of sterility assurance. The affected product is identified by Lot 12112019@10 with an expiration date of 12/20/2019.

The product was distributed nationwide within the United States. The FDA has classified this recall as Class II. No specific number of affected units or reported illnesses is provided in the source text.

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

The recalled product

Product
BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable Medication
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)

  • Lot: 12112019@10 Exp. 12/20/2019

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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