CLASS II Drug recall · Reported 15 Apr 2020 · FDA Enforcement Report
Testosterone Cypionate In Sesame Oil 200mg/ml, Injectable recalled
Innovative Intrathecal Solutions is recalling Testosterone Cypionate In Sesame Oil 200mg/ml, Injectable, distributed in California, Maine, Texas. The recall was initiated on 26 Mar 2020 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-1098-2020
- FDA event ID
- 85351
- Recalling firm
- Innovative Intrathecal Solutions, Murrieta, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2020
- FDA classified
- 6 Apr 2020
- Reported
- 15 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Mar 2020 | Recall initiated by company | |
| 6 Apr 2020 | Classified by FDA | +11 days |
| 15 Apr 2020 | 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 Assurance of Sterility
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
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Where it was distributed
Patient Distribution list includes addresses in the following states: CA, ME, TX
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 11152019@41,Expires after 04-07-2020; Lot # 12042019@12, Expires after 04-26-2020; Lot # 12172019@9, Expires after 05-09-2020; Lot # 01032020@49, Expires after 05-26-2020; Lot # 01162020@55, Expires after 06-08-2020
Where was it sold?
Patient Distribution list includes addresses in the following states: CA, ME, TX
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 85351| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B recalled | Innovative Intrathecal Solutions | Sterility | CA, ME, TX | |
| CLASS II | Methylcobalamin Soln recalled by Innovative Intrathecal | Innovative Intrathecal Solutions | Sterility | CA, ME, TX | |
| CLASS II | Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj recalled | Innovative Intrathecal Solutions | Sterility | CA, ME, TX | |
| CLASS II | Hydroxyprogesterone Caproate (BUD) 350mg/ml , Injectable recalled | Innovative Intrathecal Solutions | Sterility | CA, ME, TX |
More recalls from Innovative Intrathecal Solutions
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydroxyprogesterone Caproate (BUD) 350mg/ml , Injectable recalled | Innovative Intrathecal Solutions | Sterility | CA, ME, TX |
| Drug | CLASS II | Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj recalled | Innovative Intrathecal Solutions | Sterility | CA, ME, TX |
| Drug | CLASS II | Methylcobalamin Soln recalled by Innovative Intrathecal | Innovative Intrathecal Solutions | Sterility | CA, ME, TX |
| Drug | CLASS II | MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B recalled | Innovative Intrathecal Solutions | Sterility | CA, ME, TX |
Other Testosterone Cypionate recalls
All 130| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Injection, 200 mg/mL, CIII recalled | Empower Clinic Services | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate | Azurity Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |