CLASS II Drug recall · Reported 5 Jun 2013 · FDA Enforcement Report
Trimix Inj 30:1:10 MDV Penile Injection, 30 and 90 day recalled
Nora Apothecary and Alternative Therapies is recalling Trimix Inj 30:1:10 MDV Penile Injection, 30 and 90 day, distributed nationwide in the US. The recall was initiated on 22 Apr 2013 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-461-2013
- FDA event ID
- 65019
- Recalling firm
- Nora Apothecary and Alternative Therapies, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2013
- FDA classified
- 29 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Apr 2013 | Recall initiated by company | |
| 29 May 2013 | Classified by FDA | +37 days |
| 5 Jun 2013 | Published in enforcement report | +7 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: FDA inspection findings resulted in concerns regarding quality control processes.
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
Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Which lots are affected?
All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Where was it sold?
Nationwide
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
42 other products · FDA event 65019This product is part of a recall event; the main page for the event is Renacidin Irrigation: Bladder Irrigation, 30 day recalled.
More recalls from Nora Apothecary and Alternative Therapies
All 43| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HCG Inj 1200un/ml MDV Subcutaneous, 30 day recalled | Nora Apothecary and Alternative Therapies | Sterility | Nationwide |
| Drug | CLASS II | Chlorhexidine Opth Soln 0.02% Opthalmic Soln, 30 day recalled | Nora Apothecary and Alternative Therapies | Sterility | Nationwide |
| Drug | CLASS II | Hydroxycobalamin Inj 1000mcg/ml MDV: Subcutaneous, 90 day recalled | Nora Apothecary and Alternative Therapies | Sterility | Nationwide |
| Drug | CLASS II | Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day recalled | Nora Apothecary and Alternative Therapies | Sterility | Nationwide |
| Drug | CLASS II | PHMB Opth Soln 0.02% Opthalmic Soln, 30 day recalled | Nora Apothecary and Alternative Therapies | Sterility | Nationwide |