The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0157-2020·Announced 2019-11-06

Innoveix Recalls Lyophilized Chorionic Gonadotropin Due to Sterility Concerns

Innoveix Pharmaceuticals is recalling 3,905 vials of Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection 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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Innoveix Pharmaceuticals Inc is recalling 3,905 vials of Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection. The recall is being conducted because of a lack of sterility assurance in the product.

The affected product is a prescription-only medication compounded by Innoveix in Addison, Texas. The recall covers specific lots with expiration dates ranging from November 2019 to July 2020. The product was distributed nationwide within the United States.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Manufacturer
Innoveix Pharmaceuticals Inc
Category
Drug — Injectable Medication
Hazard
Affected units
3,905

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 (10)

  • Lot #: INX 530 Exp. 11/6/19
  • INX 535 Exp. 11/15/19
  • INX 540 Exp. 2/1/20
  • INX 545 Exp. 2/15/20
  • INX 550 Exp. 3/9/20
  • INX 555 Exp. 3/26/20
  • INX 560 Exp. 5/3/20
  • INX 565 Exp. 5/18/20
  • INX 570 Exp. 6/28/20
  • INX 575 Exp. 7/18/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Innoveix Pharmaceuticals Inc 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 4 products in this recall →

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