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Article: FDA WARNS COMPANIES TO STOP MARKETING UNAPPROVED OPHTHALMIC BALANCED SALT SOLUTION DRUG PRODUCTS, TOPICAL DRUG PRODUCTS CONTAINING PAPAIN
- Article from:
- US Fed News Service, Including US State News
- Article date:
- September 23, 2008
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The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:
The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.
Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009. After these dates, all ...