Withdrawn List

Withdrawn List

TABLE OF CONTENTS

This Appendix contains the background documentation for the Proposed Rule, List of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness

· For those products for which FDA formally withdrew the approval for safety reasons, the final Federal Register (FR) notice announcing the withdrawal is provided. In some cases, supplementary information is provided (e.g., a Notice of Opportunity for Hearing or DESI notice).

· Some products were withdrawn or removed from the market through entries in the Code of Federal Regulations (CFR). For these products, the CFR citation is provided.

· For those products that were removed from the market by the manufacturer for safety reasons and for which neither an FR notice nor CFR citation exists, informal source documentation is provided, such as a Press Release, an FDA Drug Study Bulletin, FDA Talk Paper, or a Dear Doctor Letter from the firm.

DRUG PRODUCTS PROPOSED FOR INCLUSION ON THE LIST

1. Adenosine Phosphate

3. Azaribine

5. Bithionol

7. Butamben

9. Carbetapentane Citrate

10. Casein, Iodinated

11. Chlorhexidine Gluconate