The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0735-2020·Announced 2020-01-22

Assurance Infusion Recalls Human Chorionic Gonadotropin Injections Due to Sterility Concerns

Assurance Infusion is recalling specific lots of HCG 10,000U/1ML injections due to a lack of sterility assurance. The affected 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are classified as Severe. While specific injury reports are not detailed in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe criteria for Class II recalls with potential for serious injury.

Plain-English summary

Assurance Infusion is recalling two vials of HCG 10,000U/1ML INJ in 4 mL vials. The recall is being conducted because of a lack of sterility assurance in the product.

The affected lots are 12162019@38 with an expiration date of 01/16/2020, and 11272019@32 with an expiration date of 12/31/2019. These products were distributed nationwide within the United States.

Consumers who have these specific lots should stop using the product and contact Assurance Infusion at (713) 533-8800 for further instructions.

The recalled product

Product
HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable Medication
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@38 Exp. 01/16/2020
  • 11272019@32 Exp. 12/31/2019

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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