Innoveix Recalls Lyophilized Human Chorionic Gonadotropin Due to Sterility Concerns
Innoveix Pharmaceuticals is recalling 290 vials of Lyophilized Human Chorionic Gonadotropin 5,500 USP Units 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 the hazard involves a lack of sterility assurance in an injectable drug, which carries a significant risk of serious injury or infection.
Plain-English summary
Innoveix Pharmaceuticals Inc is recalling 290 vials of Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection. The product is compounded by Innoveix in Addison, TX, and was distributed nationwide within the United States. The specific lot affected is INX 50 with an expiration date of 5/1/20.
The recall was initiated because of a lack of sterility assurance. This means the product may not be sterile, which poses a risk of infection if administered to patients.
Patients and healthcare providers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Manufacturer
- Innoveix Pharmaceuticals Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 290
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: INX 50 Exp. 5/1/20
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 →Related recalls
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