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Nora Apothecary and Alternative Therapies, Inc.: 43 FDA recall reports

Every drug recall the FDA has published for Nora Apothecary and Alternative Therapies, Inc.. The fault, and how the agency graded it.

43Reports

0Class I

0Ongoing

2013-06-05Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	43

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,

D-489-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,
Where it went: Nationwide
How much: 2

Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,

D-456-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: 8

Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,

D-471-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Where it went: Nationwide
How much: N/A

Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,

D-463-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Where it went: Nationwide
How much: N/A

Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,

D-464-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: 1

PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,

D-457-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: N/A

Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,

D-465-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: N/A

HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,

D-479-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,
Where it went: Nationwide
How much: N/A

Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration

D-491-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
Where it went: Nationwide
How much: 2

Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration,

D-469-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration,
Where it went: Nationwide
How much: 1

Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration,

D-470-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Where it went: Nationwide
How much: N/A

PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration,

D-460-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: 2

PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,

D-458-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: 37

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

D-453-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: 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,
Where it went: Nationwide
How much: 5

Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,

D-484-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,
Where it went: Nationwide
How much: 11

Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,

D-461-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Where it went: Nationwide
How much: 2

Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,

D-454-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: 5

Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,

D-486-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
Where it went: Nationwide
How much: 3

HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration,

D-478-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration,
Where it went: Nationwide
How much: N/A

Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,

D-481-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Where it went: Nationwide
How much: N/A

Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration,

D-466-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: 1

Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration,

D-468-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration,
Where it went: Nationwide
How much: N/A

Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,

D-473-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,
Where it went: Nationwide
How much: 7

Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,

D-485-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,
Where it went: Nationwide
How much: 2

Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,

D-462-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,
Where it went: Nationwide
How much: 72

PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration,

D-459-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration,
Where it went: Nationwide
How much: N/A

HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,

D-476-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,
Where it went: Nationwide
How much: 3

M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,

D-492-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,
Where it went: Nationwide
How much: 2

Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration,

D-467-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration,
Where it went: Nationwide
How much: 2

Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,

D-490-2013 · Class II · reported 2013-06-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
Where it went: Nationwide
How much: N/A

Showing the 30 most recent of 43. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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