The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0734-2020·Announced 2020-01-22

Assurance Infusion Recalls HCG Injection Vials Due to Sterility Concerns

Assurance Infusion is recalling HCG 1,000U/1ML injection vials nationwide due to a lack of sterility assurance. Consumers should stop using the product and contact their healthcare provider.

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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable drug corresponds to a Severe (4) rating.

Plain-English summary

Assurance Infusion is recalling HCG 1,000U/1ML injection vials (4 mL) distributed nationwide in the United States. The recall was initiated due to a lack of sterility assurance for the product.

The affected product consists of 5 vials per unit. Specific lots involved in the recall include 11252019@27 (Exp. 12/29/2019), 11272019@30 (Exp. 12/31/2019), 12112019@16 (Exp. 01/14/2020), and 12062019@7 (Exp. 01/09/2020).

Consumers who have this product should stop using it immediately and contact their healthcare provider or Assurance Infusion at (713) 533-8800 for further instructions.

The recalled product

Product
HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable
Hazard
Affected units
5

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 (4)

  • Lots: 11252019@27 Exp. 12/29/2019
  • 11272019@30 Exp. 12/31/2019
  • 12112019@16 Exp. 01/14/2020
  • 12062019@7 Exp. 01/09/2020

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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