CLASS II Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units recalled
Innoveix Pharmaceuticals is recalling Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, distributed nationwide in the US. The recall was initiated on 10 Oct 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0158-2020
- FDA event ID
- 84006
- Recalling firm
- Innoveix Pharmaceuticals, Addison, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2019
- FDA classified
- 28 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Oct 2019 | Recall initiated by company | |
| 28 Oct 2019 | Classified by FDA | +18 days |
| 6 Nov 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Sterility Assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection recalled?
Yes. Innoveix Pharmaceuticals recalled Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection on 10 Oct 2019. The recall is Class II and its status is Terminated. Recall number D-0158-2020.
Why was it recalled?
Lack of Sterility Assurance.
Which lots are affected?
Lot #: INX 910 Exp. 2/7/20; INX 915 Exp. 3/12/20
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Innoveix Pharmaceuticals
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Compounded Lyophilized AOD recalled by Innoveix Pharmaceuticals | Innoveix Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Compounded Lyophilized Semorelin/Ipamorelin 3 mg recalled | Innoveix Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection recalled | Innoveix Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Lyophilized Sermorelin w/ GHRP2 3 mg For injection recalled | Innoveix Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Lyophilized Human Chorionic Gonadotropin 5,500 USP Units recalled | Innoveix Pharmaceuticals | Sterility | Nationwide |