Drug recall: Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90…
Class II FDA enforcement event 65019. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II, in the words of FDA
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
Nora Apothecary and Alternative Therapies, Inc. started this drug recall on 22 Apr 2013. The firm address in the FDA record is in Indianapolis, IN. FDA put the recall in Class II. FDA event 65019 has 43 product records. The first FDA enforcement report date is 5 Jun 2013. The record gives the status Terminated, with the termination date 1 Aug 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
43 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-453-2013 | Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration, | 5 | Class II | Terminated | 5 Jun 2013 |
| D-454-2013 | Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration, | 5 | Class II | Terminated | 5 Jun 2013 |
| D-455-2013 | Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration, | 128 | Class II | Terminated | 5 Jun 2013 |
| D-456-2013 | Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration, | 8 | Class II | Terminated | 5 Jun 2013 |
| D-457-2013 | PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-458-2013 | PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration, | 37 | Class II | Terminated | 5 Jun 2013 |
| D-459-2013 | PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-460-2013 | PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration, | 2 | Class II | Terminated | 5 Jun 2013 |
| D-461-2013 | Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration, | 2 | Class II | Terminated | 5 Jun 2013 |
| D-462-2013 | Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration, | 72 | Class II | Terminated | 5 Jun 2013 |
| D-463-2013 | Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-464-2013 | Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration, | 1 | Class II | Terminated | 5 Jun 2013 |
| D-465-2013 | Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-466-2013 | Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration, | 1 | Class II | Terminated | 5 Jun 2013 |
| D-467-2013 | Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration, | 2 | Class II | Terminated | 5 Jun 2013 |
| D-468-2013 | Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-469-2013 | Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration, | 1 | Class II | Terminated | 5 Jun 2013 |
| D-470-2013 | Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-471-2013 | Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-472-2013 | Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, | 1 | Class II | Terminated | 5 Jun 2013 |
| D-473-2013 | Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration, | 7 | Class II | Terminated | 5 Jun 2013 |
| D-474-2013 | PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, | 2 | Class II | Terminated | 5 Jun 2013 |
| D-475-2013 | Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-476-2013 | HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration, | 3 | Class II | Terminated | 5 Jun 2013 |
| D-477-2013 | HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration, | 3 | Class II | Terminated | 5 Jun 2013 |
| D-478-2013 | HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-479-2013 | HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-480-2013 | Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration, | 7 | Class II | Terminated | 5 Jun 2013 |
| D-481-2013 | Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-482-2013 | Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-483-2013 | Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration, | 14 | Class II | Terminated | 5 Jun 2013 |
| D-484-2013 | Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration, | 11 | Class II | Terminated | 5 Jun 2013 |
| D-485-2013 | Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration, | 2 | Class II | Terminated | 5 Jun 2013 |
| D-486-2013 | Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, | 3 | Class II | Terminated | 5 Jun 2013 |
| D-487-2013 | Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration, | 5 | Class II | Terminated | 5 Jun 2013 |
| D-488-2013 | Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration, | 5 | Class II | Terminated | 5 Jun 2013 |
| D-489-2013 | Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration, | 2 | Class II | Terminated | 5 Jun 2013 |
| D-490-2013 | Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-491-2013 | Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration | 2 | Class II | Terminated | 5 Jun 2013 |
| D-492-2013 | M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration, | 2 | Class II | Terminated | 5 Jun 2013 |
| D-493-2013 | Lidocaine 2% Inj MDV, 20 ml 30 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-494-2013 | Meperidine 100mg/ml MDV, 5ml 90 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
| D-495-2013 | Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration, | N/A | Class II | Terminated | 5 Jun 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class II
- 56%
- Product records in this event
- 43
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-453-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 65019. https://recallregister.com/fda/ii/65019/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 65019?
- The event has 43 product records. The first record gives this quantity:
5
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 56% of the 370 drug events that started in 2013 are in Class II.