The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating through grants or contracts.
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Personal Importation
Personal ImportationList of Determinations Including Written Request
In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product
Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored.Mr. Strong Guy Honey For Him contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Mr. Strong Guy Honey For Him, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.Dollar General Announces Voluntary Recall of Clover Valley® Instant Coffee Due to Potential Presence of Glass
Goodlettsville, Tennessee – August 11, 2025 –Dollar General Corporation is recalling three (3) lots of its eight (8) ounce Clover Valley® Instant Coffee due to the potential presence of glass.Medical Chemical Corporation – 706007 – 07/09/2025
CGMP/Finished Pharmaceuticals/Adulterated