From: tculkin@watsonpharm.com
Sent: Wednesday, February 26, 2003 12:10 PM
To: fdadockets@oc.fda.gov
Subject: [DOCID:fr03fe03-62]; Mercury Compounds in Drugs and Food

See our comments, below:
---------------------- Forwarded by Thomas T Culkin/Brewster/Watson on
02/26/2003 12:09 PM ---------------------------


Thomas T Culkin
02/26/2003 12:02 PM

To:   %20fdadockets@oc.fda.gov
cc:   Greg Torre/Morristown/Watson@Watson, Sue Crane/Georgia/Watson@Watson

Subject:  [DOCID:fr03fe03-62]; Mercury Compounds in Drugs and Food

We note that this February 3, 2003, Federal Register document lists 7 Schein
Pharmaceutical-labeled products that may have contained mercury in some form.
Our comments are given below:

1. Schein Pharmaceutical Neomycin Polymyxin B Sulfates Hydrocortisone Ophthalmic
Suspension
     Comment: This product was discontinued on 10/29/98; it contained Thimerosal
0.001%.

2. Schein Pharmaceutical Sulfacetamide Sodium & Prednisolone Sodium Phosphate
Ophthalmic Solution
     Comment: This product was discontinued on 10/29/98; it contained Thimerosal
0.1 mg/mL.

3. Schein Pharmaceutical Testosterone Injection Suspension 100 mg
     Comment: This product was discontinued on 9/13/96; it contained Thimerosal
0.08 mg/mL.

4. Schein Pharmaceutical Neomycin Polymyxin B Sulfates Hydrocortisone Otic
Suspension
     Comment: This product was discontinued 4/9/99; it contained Thimerosal
0.01%.

5. Schein Pharmaceutical Trifluridine Ophthalmic Solution
     Comment: This product was discontinued on 10/29/98; it contained Thimerosal
0.001%.

6. Schein Pharmaceutical Oxymetazoline HCl Nasal Spray
     Comment: Schein Pharmaceutical did not manufacture this product, it was
manufactured for us by Thames Pharmacal.   It was discontinued    under the
Schein label on 7/2/98; we do not know if it contained any mercury, nor whether
it has been reformulated.

7. Schein Pharmaceutical Phenylephrine HCl Nasal Solution 1%
     Comment: Schein Pharmaceutical did not manufacture this product; it was
manufactured for us by Barre-National (now Alpharma).  It was     discontinued
on 2/14/94.  We do not know if it contained any mercury, nor whether it has been
reformulated.

Thomas T. Culkin, PharmD, MSc, MPH, RPh
Executive Director, Regulatory Operations
Watson Laboratories, Inc. (Watson purchased Schein Pharmaceutical Inc. two years
ago.)
39 Mt. Ebo Drive South
Brewster, NY 10509
845-278-3724
845-278-3824 (fax)