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Mercury in Drug and Biologic Products

FDA/Center for Drug Evaluation and Research
 

The information in this list is derived from submissions made by manufacturers in response to the agency's call-for-data notices of December 14, 1998 (63 FR 68775) and April 29, 1999 (64 FR 23083), the agency's Drug Registration and Listing System, and other agency sources. The mercury ingredients are abbreviated as TM for thimerosal, PMA for phenylmercuric acetate, PMN for phenylmercuric nitrate, MA for mercuric acetate, MN for mercuric nitrate, MB for merbromin, and MOY for mercuric oxide yellow. The list includes nonhomeopathic human and veterinary drug products and human biological products. Homeopathic drug products are not included because of the low amounts of mercury present in the product. The abbreviation NS under the % column means that the information was "not stated" in the agency's Drug Registration and Listing System.

Manufacturer

Name of Product

Ingredient

%

Akorn Inc.

AK Spore Ophthalmic Solution

TM

.001

Akorn Inc.

AK Spore HC Ophthalmic Combo Drops

TM

NS

Akorn Inc.

Fluoracaine Ophthalmic Solution

TM

NS

Akorn Inc.

AK Spore HC Otic Suspension

TM

NS

Alcon Laboratories

Profenal 1% Ophthalmic Solution

TM

.005

Alcon Laboratories

Adsorbonac 2% Ophthalmic Solution

TM

.004

Alcon Laboratories

Adsorbonac 5% Ophthalmic Solution

TM

.004

ALK Laboratories Pharmacia

Coccidioidin Vaccine

TM

.01

Allergan Inc.

Blephamide SOP Ophthalmic Ointment

PMA

.0008

Allergan Inc.

Bleph-10 Ophthalmic Ointment 10%

PMA

.0008

Allergan Inc.

FML SOP Ophthalmic Ointment 0.1%

PMA

.0008

Allergan America

Ocufen Ophthalmic Solution

TM

.005

Allergan Inc.

Poly Pred Ophthalmic Suspension

TM

.001

Allergan America

Poly Pred Ophthalmic Suspension

TM

.001

Altaire Pharmaceuticals

Nasal Relief 12 Hour Spray

PMA

NS

American Assn. Retired Persons

Oxymetazoline Nasal Spray

PMA

.002

American International Chemical

Thimerosal (bulk chemical)

TM

100

American International Chemical

Thimerosal (bulk chemical)

TM

100

American International Chemical

Thimerosal USP 97% (bulk chemical)

TM

97

American Pharmaceutical

12 Hour Nasal Solution

PMA

NS

Appletree Markets

Long Lasting Nasal Spray

PMA

NS

B. F. Ascher & Co.

Baby AYR Saline Nose Spray/Drops

TM

.00025

B. F. Ascher & Co.

AYR Saline Nasal Drops

TM

.00025

B. F. Ascher & Co.

AYR Saline Nasal Mist

TM

.00025

Bausch & Lomb

Flurbiprofen Sodium Ophthalmic Solution

TM

.005

Bausch & Lomb

Neomycin & Polymyxin B Sulfates & Gramicidin Ophthalmic Solution

TM

.001

Bausch & Lomb

Neomycin & Polymyxin B Sulfates & Hydrocortisone Otic Suspension

TM

.01

Bausch & Lomb

Sulfacetamide Sodium & Prednisolone Sodium Phosphate Ophthalmic Solution 10%/.23%

TM

.01

Baxter Healthcare Corporation

Immune Globulin Vaccine

TM

.01

Bayer Corporation

Nasal Saline Moisturizer Spray

TM

.001

Bayer Corporation

Neo-Synephrine 12-Hour Nasal Decongestant Spray

PMA

.002

Bayer Corporation

Neo-Synephrine Extra Strength Drops

TM

.001

Bayer Corporation

Neo-Synephrine Mild Formula Spray

TM

.001

Bayer Corporation

Neo-Synephrine Regular Strength Spray

TM

.001

Bayer Corporation

Neo-Synephrine Extra Strength Spray

TM

.001

Bayer Corporation

Neo-Synephrine Regular Strength Drops

TM

.001

Bayer Corporation

Neo-Synephrine 12-Hour Extra Moisturizing Spray

PMA

.002

Berna Products

Tetanus Vaccine Adsorbed

TM

.01

Bioport Corporation

Tetanus Toxoid Adsorbed

TM

.01

Bioport Corporation

Rabies Vaccine Adsorbed

TM

.01

Bioport Corporation

Immune Globulin (Human)

TM

01

Bioport Corporation

Pertussis Vaccine Adsorbed

TM

.01

Bioport Corporation

Diphtheria & Tetanus Toxoids Adsorbed

TM

.01

Bioport Corporation

Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed

TM

.01

Bristol-Myers Squibb

Fungizone Lotion

TM

.01

Bristol-Myers Squibb

Fungizone Cream

TM

.01

C.O. Truxton Inc.

Bio-Cot Otic Suspension

TM

.01

C.O. Truxton Inc.

Decongest Nasal Spray

PMA

NS

Carlisle Laboratories

Oxymetazoline Nasal Relief Spray

PMA

NS

Carlisle Laboratories

Neomycin Polymyxin B Sulfates Gramicidin Ophthalmic Solution

TM

.01

Carlisle Laboratories

Neomycin Polymyxin B Sulfates Hydrocortisone Otic Suspension

TM

.01

Cheshire Pharmaceutical

Otocort Otic Suspension

TM

.01

Cheshire Pharmaceutical

Ocutricin Ophthalmic Solution

TM

.01

Cheshire Pharmaceutical

Sulfapred Ophthalmic Solution

TM

NS

Clay Park Labs.

PREP Hemorrhoidal Ointment

MN

NS

Clay Park Labs.

Little Noses Saline Spray/Drops

MA

.002

Clay Park Labs

Cheracol Nasal Spray 12 Hour

PMA

.005

Clay Park Labs

PREP-HEM Hemorrhoidal Suppositories

PMN

NS

Clay Park Labs

Long Acting Nasal Spray

PMA

NS

Conair Corp.

Decongestant Nasal Spray

PMA

NS

Connaught Laboratories

Diphtheria & Tetanus Toxoids Adsorbed

TM

.01

Connaught Laboratories

Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed

TM

.01

Connaught Laboratories

Mumps Skin Test Antigen

TM

.01

Connaught Laboratories

Influenza Virus Vaccine, Trivalent, Types A & B

TM

.01

Connaught Laboratories

Tetanus Toxoid for Booster Use Only

TM

.01

Connaught Laboratories

Influenza Virus Vaccine, Trivalent, Types A & B

TM

.01

Connaught Laboratories

Haemophilus b Conjugate Vaccine Reconstituted with Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

TM

.01

Connaught Laboratories

Tetanus Toxoid Adsorbed

TM

.01

Connaught Laboratories

Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

TM

.01

Connaught Laboratories

Haemophilus b Conjugate Vaccine

TM

.01

Connaught Laboratories

Tetanus and Diphtheria Toxoids Adsorbed

TM

.01

Connaught Laboratories

Japanese Encephalitis Virus Vaccine

TM

.007

Connaught Laboratories

Diluent for Meningococcal Vaccine Groups

TM

0.1

CVS Revco DS Inc.

12 Hour Decongestant Pump Nasal Spray

PMA

NS

CVS

Nasal Spray Pump

PMA

NS

Darby Group Companies

Neomycin Polymyxin B Sulfates Hydrocortisone Otic Suspension

TM

.01

Dolder Ltd.

Thimerosal (bulk chemical)

TM

100

Dorex International Corp.

Long Acting Nasal Spray

PMA

.002

Drug Guild Distributors

Long Acting Decongestant Nasal Spray

PMA

NS

Drug Guild Distributors

Nasal Spray 12 Hour Pump

PMA

NS

Drug Guild Distributors

Long Acting Nasal Spray Kolex LA

PMA

.002

DRX Pharmaceutical

Blephamide Ophthalmic Ointment

PMA

NS

DRX Pharmaceutical

Cortisporin Ophthalmic Suspension

TM

.001

DRX Pharmaceutical

Neomycin Polymyxin B Sulfates Hydrocortisone Ophthalmic Suspension

TM

NS

DRX Pharmaceutical

Neomycin Polymyxin B Hydrocortisone Otic Suspension

TM

.01

DRX Pharmaceutical

Neomycin Polymyxin B Gramicidin Ophthalmic Solution

TM

.01

DRX Pharmaceutical

Vasocidin Ophthalmic Solution

TM

NS

DRX Pharmaceutical

Colymycin S Otic Suspension

TM

.002

DRX Pharmaceutical

Pediotic Otic Suspension

TM

NS

Dysers Sal

Thimerosal (bulk chemical)

TM

NS

Family Independent Pharmacy

12 Hour Nasal Decongestant Spray

PMA

NS

Family Independent Pharmacy

Long Acting Nasal Spray

PMA

NS

Farm Fresh Inc.

Hemorrhoid Relief Ointment

PMN

.01

Fays Drug Services

12 Hour Nasal Spray Pump

PMA

NS

Federated Foods

Long Acting Nasal Spray

PMA

.002

Fleming Companies

12 Hour Nasal Spray

PMA

.002

Foxmeyer Drug Co.

Nasal Spray Pump

PMA

NS

Global Source

Nasin Long Acting Nasal Spray

PMA

NS

Harco Drug

Mercurochrome Aqueous Solution

MB

2

Harris-Teeter

Oxymetazoline Nasal Spray

PMA

.002

Hi Tech Pharmacal Co.

Long Acting Nasal Spray

PMA

.002

Hudson Corp.

Nasal Spray Extended Relief

PMA

NS

Hurst Pharmaceutical

Duomycin-HC Otic Suspension

TM

.01

K and B Distributors

Mercurochrome Aqueous Solution

MB

2

King Pharmaceuticals

Cortisporin Ophthalmic Suspension

TM

.001

King Pharmaceuticals

Neosporin Ophthalmic Suspension

TM

.001

King Pharmaceuticals

Viroptic Ophthalmic Solution

TM

.001

King Pharmaceuticals

Neomycin Polymyxin B Sulfates Hydrocortisone Otic Suspension

TM

NS

King Pharmaceuticals

Pediotic Suspension

TM

.001

King Pharmaceuticals

Cortisporin Otic Suspension

TM

.01

Kinray

Oxymetazoline Nasal Spray

PMA

.002

Laboratori Derivati

Adrenal Cortex Injection

TM

.01

Leader

12 Hour Nasal Spray

PMA

NS

Leader

Nasal Pump Spray

PMA

NS

Longs Drug Stores

Nasal Spray Pump

PMA

NS

LS Raw Materials Ltd.

Mercurochrome NF 12 100% (bulk chemical)

MB

100

Major Pharmaceuticals

Cortomycin Ophthalmic Suspension

TM

NS

Major Pharmaceuticals

Sulfacetamide Sodium & Prednisolone Sodium Phosphate Ophthalmic Solution

TM

.01

Major Pharmaceuticals

Cortomycin Otic Suspension

TM

.01

Major Pharmaceuticals

Neocidin Ophthalmic Solution

TM

.01

Martin Surgical Supply

Testosterone Injection Suspension 50 mg

TM

.008

Martin Surgical Supply

Testosterone Injection Suspension 100 mg

TM

NS

Massachusetts Public Health

Biologic Labs

Tetanus and Diphtheria Toxoids Adsorbed

For Adult Use

TM

.003

Massachusetts Public Health

Biologic Labs